Date Initiated by Firm | July 13, 2023 |
Date Posted | September 30, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2422-2023 |
Recall Event ID |
92561 |
510(K)Number | K930667 |
Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
|
Product | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device |
Code Information |
UDI/DI 10885403160578, Lot Numbers: C23, L22 |
Recalling Firm/ Manufacturer |
Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845
|
For Additional Information Contact | 847-823-5433 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 4 units |
Distribution | US and Canada |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = GCJ
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