—#129215

Product

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.

FDA product code: NGT — Saline, Vascular Access Flush
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K042061
Affected lot / code info: 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) Syringes Ref #306553, 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; Kit Code/Description: DT17300/NEONATAL CAP CHANGE KIT, Lot Numbers: 2013052880, 2013111880; Kit Code/Description: DT17410/ON/OFF KIT & DRESSING CHANGE TRAY, Lot Numbers: 2013050680, 2013061780; Kit Code/Description: DT17880C/DRIVELINE MGMT SYST - PROTOCOL 2, Lot Number: 2013040180; Kit Code/Description: ECVC150/MULTI-LUMEN CVC KIT W/ELS VANTEX CATHETE, Lot Number: 2013091950; Kit Code/Description: ECVC355/ CHARLES COLE CVC INSERTION BUNDLE, Lot Numbers: 2013082050, 2013091950; Kit Code/Description: ECVC510/CENTRAL LINE INSERTION TRAY, Lot Number: 2013081550; Kit Code/Description: ECVC585/CENTRAL LINE INSERTION TRAY BUNDLE, Lot Number: 2013082950; Kit Code/Description: ECVC705/7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Lot Number: 2013091750; Kit Code/Description: ECVC740/MULTI-LUMEN CVC BUNDLE, Lot Number: 2013092650; Kit Code/Description: HT5525/V.A.D.KIT, Lot Number: 2013062480; Kit Code/Description: HT5545/SUB-PORT ACCESS TRAY: Lot Number: 2013052880; & Kit Code/Description: IV7610/ARTERIAL LINE INSERTION KIT, Lot Numbers: 2013052080.

Why it was recalled

Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.

Root cause (FDA determination)

Packaging

Action the firm took

Centurion sent an Urgent Product Recall Notice dated July 25, 2014, to all affected customers via Certified Mail. The notification discussed the affected product issue and provided instructions for initiating product return. Customers were instructed to identify and remove all inventory of these kits that they may have within their possession. Customers were asked to forward a copy of the notice to any customers to whom this product may have been further distributed. Customers were also asked to complete the enclosed accountability record, whether or not they have the product, and fax or email at their earliest convenience to 517-546-3356 or lcarpenter@centurionmp.com. Customers with questions were instructed to call (517) 546-5400, Ext 1135. For questions regarding this recall call 517-546-5400, ext 1156.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: The product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, TX, VA, NC, IL, MA, OR, WA, IN, SD.

Timeline

Recall initiated: 2014-07-25
Posted by FDA: 2014-09-19
Terminated: 2014-11-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129215. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.