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U.S. Department of Health and Human Services

Class 2 Device Recall Carefusion SnowdenPencer MIS DIAMONDTOUCH DISSECTOR DIAMOND JAW

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 Class 2 Device Recall Carefusion SnowdenPencer MIS DIAMONDTOUCH DISSECTOR DIAMOND JAWsee related information
Date Initiated by FirmJuly 13, 2023
Date PostedSeptember 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2429-2023
Recall Event ID 92561
510(K)NumberK930667 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductSnowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device
Code Information UDI/DI 10885403161544, Lot Numbers: B23, C23
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
ActionBD 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 Commerce20 units
DistributionUS and Canada
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = GCJ
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