Reported Oct 1, 2014 · Terminated
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion…
Centurion Medical Products Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Centurion Medical Products Corporation · 100 Centurion Way · Williamston, MI · 48895-9086
Is this the product you have?
- 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.
- Lot codes and dates
32 of 32 products
Products covered by this recall Model / number Product as published 3065539% Sodium Chloride Injection, USP BD PosiFlush(TM) Syringes , Lot Numbers 4128353, 3046276, 3024261 were utilized in the following Centurion convenience kits: Kit Code/Description: CVI3210/UNIVERSAL CENTRAL LINE INSERTION, Lot Numbers: 2013082850, 2013092650 — Kit Code/Description: CVI3240/PORT ACCESS KIT, Lot Number: 2013111180 — Kit Code/Description: CVI3425/CVC UNIVERSAL BUNDLE, Lot Numbers: 2013081350,2013082950, 2013091250 — Kit Code/Description: CVI3525/UNIVERSAL BUNDLE PACK, Lot Number: 2013052880 — Kit Code/Description: CVI3535/CENTRAL LINE INSERTION TRAY, Lot Numbers: 2013092450, 2013081950 — Kit Code/Description: DT10560/INFUSION PORT ACCESS KIT, Lot Number: 2013061780 — Kit Code/Description: DT10620/FISTULA KIT, Lot Number: 2013082150 — Kit Code/Description: DT11270/VAD KIT, Lot Number: 2013051380 — Kit Code/Description: DT11390/ONCOLOGY PORT ACCESS TRAY (MED GLOVES), Lot Numbers: 2013052080, 2013072980 — Kit Code/Description: DT11395/ONCOLOGY PORT ACCESS (NO GLOVES), Lot Numbers: 2013052880, 2013111180 — Kit Code/Description: DT12955/UNIVERSAL PROCEDURE PACK, Lot Number: 2013091750 — Kit Code/Description: DT13610/PICC INSERTION KIT, Lot Numbers: 2013061780, 2013062480 — Kit Code/Description: DT13775/PORT ACCESS/CENTRAL LINE TRAY, Lot Number: 2013052080 — Kit Code/Description: DT14645/PORT ACCESS TRAY, Lot Number: 2013120280 — Kit Code/Description: DT14680/CAP CHANGING KIT, Lot Numbers: 2013061080, 2013061780 — Kit Code/Description: DT14835/CAP CHANGE KIT, Lot Number: 2013111180 — Kit Code/Description: DT14860/PORT DRESSING CHANGE KIT WITH MED SHIELD, Lot Number: 2013102880 — Kit Code/Description: DT15060/SINGLE PORT ACCESS TRAY W/SORBAVIEW, Lot Numbers: 2013050680, 2013040180, 2013061080 — Kit Code/Description: DT15220/STERILE CAP CHANGE, Lot Numbers: 2013052880, 2013061080 — Kit Code/Description: DT16040/PORT ACCESS TRAY, Lot Numbers:, 2013052880,2013061780, 2013072980, 2013111180 - Amount recalled
- 21388
Where it was sold
Why it was recalled
Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.
This product could cause temporary or reversible health problems — stop using it.
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