Recall Z-1014-2011 ยท LRS I.V. Start Kit
Centurion Medical Products
Port Access Tray "for use with power ports" Reorder DT9405C, Sterile, Centurion Medical Products Corp. Williamston, MI Intended use: Vascular access port kit
| Date | Feb 1, 2011 (initiated Dec 6, 2010) |
| Status | Terminated |
| Reason | The firm is conducting a recall of kits that contain the MONOJECT PREFILL ADVANCED flush syringes containing heparin. The syringes are under recall by their manufacturer Coviden because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium USP contained low level of Over-Sulfated Chondroitin Sulfate (OSCS)". |
| Root cause | Other |
| Action | The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated November 12, 2010, to affected customers via Certified Mail, Return Receipt Requested. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and in-use stock to determine if they have any units of the affected product, if found, immediately remove from inventory and quarantine; if they are a distributor they were ask to notify their customers of this letter; and complete and return the PRODUCT RECALL FORM whether or not they have the affected |
| Quantity | 400 kits |
| Distribution | Nationwide Distribution: USA including states of: OH, WI, IL, MO and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.