FDA Medical Device Recalls (openFDA)
American Contract Systems, Inc.: Various PICC Line, Central Line Packs
- Recall number
- Z-1692-2022
- Recalling firm
- American Contract Systems, Inc.
- Product
- Various PICC Line, Central Line Packs
- Status
- Open, Classified
- Initiated
- 2022-06-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- Root cause
- Process change control
- Action
- The recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022. Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm. A Field Action Response Form should be completed and returned to angela.bunn@owens-minor.com as soon as possible, even if the customer has no inventory. If you have any questions, please call 816-920-5846.
- Quantity
- 2 units
- Distribution
- Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
- Lot, serial or model codes
- Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRPICCLINEH, 2105051, 884211, 14886484 2) UICL44M, 2107142, 807211, 64164800
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFF
- Firm FEI
- 3003419114
- Firm city
- Kansas City
- Firm state
- MO
- 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