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 Recall Z-2670-2014 · Posted 2014-09-19
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Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeNGT
Date Initiated2014-07-25
Date Terminated2014-11-25
Product Quantity21388
Reason for Recall
Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.
Firm Action
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 [email protected].
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
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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