0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenie

FDA device recall Z-2670-2014 · posted 2014-09-19 · Terminated

Recall details

Recalling firm

Centurion Medical Products Corporation

Reason for recall

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

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

NGT

Quantity affected

21388

Distribution

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.

Date initiated

2014-07-25

Date posted

2014-09-19

Date terminated

2014-11-25

Location

Williamston, MI

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