FDA Medical Device Recalls (openFDA)
Covidien LP: MONOJECT Blood Collection Tubes containing heparin 10x50 Sodium Heparin Item code 8881320157
- Recall number
- Z-1570-2011
- Recalling firm
- Covidien LP
- Product
- MONOJECT Blood Collection Tubes containing heparin 10x50 Sodium Heparin Item code 8881320157
- Status
- Terminated
- Initiated
- 2010-11-15
- Posted
- 2011-03-07
- Terminated
- 2015-12-04
- 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
- 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
- Lot, serial or model codes
- Lot # 918210
- 510(k) numbers
- ["K883320"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28