FDA Medical Device Recalls (openFDA)
Continental Medical Labs,Inc: Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. Q921CL, Manufactured for : Blood Center of Wisconsin, Milwaukee, WI. Port VAD Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. 3540CL, Manufactured for : McCormick Medical Distribution, Edmonds, WA 98020. The kits are used by blood centers to draw blood.
- Recall number
- Z-0894-2011
- Recalling firm
- Continental Medical Labs,Inc
- Product
- Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. Q921CL, Manufactured for : Blood Center of Wisconsin, Milwaukee, WI. Port VAD Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. 3540CL, Manufactured for : McCormick Medical Distribution, Edmonds, WA 98020. The kits are used by blood centers to draw blood.
- Status
- Terminated
- Initiated
- 2010-12-06
- Posted
- 2011-01-11
- Terminated
- 2012-07-05
- Reason
- Continental Medical labs, Inc, is recalling various lots of Blood Center Kit and Port VAD Kits because Covidien reported that testing could not pick up an Over-Sulfated Chondroitin Sulfate (OSCS) contaminant in the purified heparin sodium USP.
- Root cause
- Material/Component Contamination
- Action
- Covidien sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to their distributors. Continental Medical Labs,Inc telephoned on 12/06/2010 and later sent a letter dated December 7, 2010, with an enclosed copy of the recall notice. The letters were addressed to McCormick Medical Distribution, Inc and to Medico Mart, Inc. The letter described the problem and product affected. Advised consignees to inform all their customers to return the product as well as the distribution information as soon as possible so CML could notify Covidien for replacements. For questions regarding this recall call (262) 723-6715, ext. 313.
- Quantity
- 30 cases, 30 kits per case
- Distribution
- Nationwide Distribution including WA and WI
- Lot, serial or model codes
- Lot 912024, 1004229, 1007091 (Reorder # Q921CL) Lot 1001066 (Reorder # 3540CL)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFM
- Firm FEI
- 2128604
- Firm city
- Waterford
- Firm state
- WI
- 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