Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical
FDA device recall Z-2417-2023 · posted 2024-09-30 · Open, Classified
Recall details
- Recalling firm
- Carefusion 2200 Inc
- 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.
- Action taken
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- GCJ
- Quantity affected
- 1 unit
- Distribution
- US and Canada
- Date initiated
- 2023-07-13
- Date posted
- 2024-09-30
- Location
- Vernon Hills, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REUSABLE LAPAROSCOPIC INSTRUMENTS (K930667) | Snowden-Pencer | 1994-05-16 |