Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
FDA Recall Z-2415-2023 · Posted 2024-09-30
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Recalling FirmCarefusion 2200 Inc
Recall StatusOpen, Classified
Product CodeGCJ
Date Initiated2023-07-13
Product Quantity3 units
Reason for Recall
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.
Firm 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: [email protected]
Root Cause
Nonconforming Material/Component
Distribution Pattern
US and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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