MONOJECT Blood Collection Tubes containing heparin 10x50 Sodium Heparin Item code 8881320157
FDA device recall Z-1570-2011 · posted 2011-03-07 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 32,000
- 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
- Date initiated
- 2010-11-15
- Date posted
- 2011-03-07
- Date terminated
- 2015-12-04
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE (K883320) | Sherwood Medical Co. | 1988-09-27 |