FDA Medical Device Recalls (openFDA)
Covidien LP: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL REF # 8881590123, Tyco Healthcare, Mansfield, MA 02048
- Recall number
- Z-1600-2008
- Recalling firm
- Covidien LP
- Product
- Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL REF # 8881590123, Tyco Healthcare, Mansfield, MA 02048
- Status
- Terminated
- Initiated
- 2008-03-28
- Posted
- 2008-05-09
- Terminated
- 2012-06-25
- Reason
- Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
- Root cause
- Material/Component Contamination
- Action
- Tyco Healthcar notifed customers by letter sent via US Postal Service beginning 3/28/08, through 4/1/08. The letter requests that they immediately stop using and return the product. Distributors are requested to in-turn notify their customers. An instruction sheet was attached for product return and replacement. All customers are required to respond to the notice regardless of remaining inventory. .
- Quantity
- 1,138,860 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers: 7041194; 7072154; 7113034; 8010194
- 510(k) numbers
- ["K032438"]
- PMA numbers
- not on file
- Product code
- NZW
- 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