FDA Medical Device Recalls (openFDA)
American Contract Systems, Inc.: American Contract Systems Gyn Laparoscopy convenience kit
- Recall number
- Z-2518-2024
- Recalling firm
- American Contract Systems, Inc.
- Product
- American Contract Systems Gyn Laparoscopy convenience kit
- Status
- Open, Classified
- Initiated
- 2024-05-06
- Posted
- 2024-08-07
- Terminated
- not on file
- Reason
- Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
- Root cause
- Under Investigation by firm
- Action
- The recalling firm issued recall letters on and dated 5/6/2024 via email or overnight mail. The letter explained the event details, product involved, risk to health, and actions to take. The actions included (1) review your inventory and segregate and quarantine all affected trays. If any of the trays have been further distributed, ensure all end users are notified and maintain records of effectiveness; (2) discard all affected kits and document on the enclosed Response Form; and (3) complete the enclosed Response Form and return it as soon as possible.
- Quantity
- 29 kits
- Distribution
- US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
- Lot, serial or model codes
- (1) Model No SLGL64K - UDI-DI 00191072202017; Lot 981241; Exp. Date 1/19/2025; and (2) Model No SMGY46A - UDI-DI 00191072188458; Lot 982241; Exp. Date 1/18/2025.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHD
- 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