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Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.

Limited official informationPatient-Relevant Medical Devices

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number...

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

AffectedBrand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors...
RiskPotential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infectio...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen des...

AffectedBreathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-M...
RiskVentilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detec...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

AffectedCinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, Ind...
RiskcGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Cod...

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

AffectedCK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Sin...
RiskDue to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampou...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposa...

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

AffectedCovidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Cov...
RiskDue to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the prod...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

CRE Pro Wireguided 12-15mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

AffectedCRE Pro Wireguided 12-15mm 240cm; CRE Pro Wireguided 10-12mm 240cm; plus 10 additional official variants listed below.
RiskPotential sterile breach of the pouches in which devices are packaged.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release...

AffectedCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
RiskIn certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the ope...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release...

AffectedCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
RiskIn certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the ope...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYST...

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

AffectedDepuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes....
RiskThe external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsu...

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

AffectedDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Ex...
RiskLabeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

GC Agar Base (150mm) 10/PK R04030

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

AffectedGC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
RiskReduced or no recovery of some strains of Neisseria gonorrhoeae.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THY...

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

AffectedGemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only,...
RiskTemperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigera...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufa...

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

AffectedGlucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syri...
RiskCGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability test...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the pre...

AffectedHillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lun...
RiskThere have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.

AffectedIntelliCuff, Portable automatic cuff pressure controller REF: 951001
RiskDue to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

Le Chef Bakery branded Mini Italian Pastry Assortment

undeclared colors (yellow#5)

AffectedLe Chef Bakery branded Mini Italian Pastry Assortment; 2.5 lbs/cs; (40 pieces/cs); packaged in generic food service p...
Riskundeclared colors (yellow#5)
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use

Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.

AffectedMEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Samp...
RiskDue to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH ME...

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breaka...

AffectedMedline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG P...
RiskKits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage invo...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its d...

AffectedMedline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390...
RiskThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notic...
ActionNot available

Missing from associated official evidence: action.