Recall Z-1460-2011 ยท LRS I.V. Start Kit
Centurion Medical Products Corporation
Universal Insertion Tray Bundle, CV13530, Sterile, Centurion Medical Products Corp., Williamston, MI. These kits are used for dressing changes.
| Date | Mar 8, 2011 (initiated Jan 14, 2011) |
| Status | Terminated |
| Reason | The firm is conducting a subrecall of kits containing Triad Groups alcohol prep pads. Triad initiated a recall of prep pads due to a concern about potential contamination of the products with an objectional orgainism, Bacillus cereus. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Centurion Medical Products, sent an "URGENT PRODUCT RECALL NOTICE" dated January 12, 2011 to affected customers via Certified Mail, Return Receipt Requested. The notice described the product, problem and action to be taken. The customers were instructed to identify and remove all inventory of the recalled kits in their possession; forward a copy of this notice to any customers that this product was further distributed to, and complete and return the attached Accountability Record form via fax to 517-546-3356 or email to: lcarpenter@centurionmp.com. The notice states that a Centuri |
| Quantity | 68056 all kits |
| Distribution | Nationwide distribution: USA including state of: CT, ID, NM, MA, MO, MT, VA and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.