FDA Medical Device Recalls (openFDA)
Carefusion 2200 Inc: Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
- Recall number
- Z-2422-2023
- Recalling firm
- Carefusion 2200 Inc
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
- Status
- Open, Classified
- Initiated
- 2023-07-13
- Posted
- 2024-09-30
- Terminated
- not on file
- Reason
- Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
- Root cause
- Nonconforming Material/Component
- Action
- BD issued an URGENT: Medical Device Product Recall notice to its consignees on 13 July 2023 via FedEx 2-day and email. The notice explained the problem with the device, the risk to the patient, and requested the following actions: Medical facilities: - Discontinue the use of the affected device and destroy it - Share the notice with all users within your facility network - If the product was purchased through a distributor, contact the distributor directly for further instructions. Distributors were directed to Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this recall notification on BD s behalf. Questions: Phone: 1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted, M-F 8am - 5pm CT Email: productcomplaints@bd.com
- Quantity
- 4 units
- Distribution
- US and Canada
- Lot, serial or model codes
- UDI/DI 10885403160578, Lot Numbers: C23, L22
- 510(k) numbers
- ["K930667"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3008002452
- Firm city
- Vernon Hills
- Firm state
- IL
- 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