Recall Z-1569-2011 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Covidien LP
MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014
| Date | Mar 7, 2011 (initiated Nov 15, 2010) |
| Status | Terminated |
| Reason | The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. |
| Root cause | Material/Component Contamination |
| Action | Covidien sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using the product, and return it to the firm. Distributors were instructed to notify their customers. All customers were required to respond to the notice regardless of their remaining inventory. Responses will be tracked for follow-up and effectiveness checks. For Customers Service questions regarding this recall call 1-800-962-9888 option 1. |
| Quantity | 18,100 |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KS, KY, MA, MI, MN, MO, MS, NC, ND, NE, NJ, NM, MV, MY, OH, OK, PA, SC, SD, TN, TX, WA, and WI and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883320 | MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE Sherwood Medical Co., Sep 27, 1988 |