Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the
FDA device recall Z-1329-2014 · posted 2014-04-03 · Open, Classified
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
- Action taken
- Ethicon sent an Urgent Medical Device Recall letter dated February 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine their inventory and determine if they have any of the affected product. If any product has been distributed, those hospitals should be notified. The business reply form should be completed and faxed or emailed to Stericycle at 1-888-641-9732 or ethicon5798@stericycle.com. For clinical or product support contact a customer representative or call the Customer Support Center at 1-877-ETHICON to speak with a registered nurse or contact Stericycle at 1-888-345-0524 and reference event #5798. Stericycle is handling returns.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FTM
- Quantity affected
- 223 units
- Distribution
- US Distribution including the states of FL, NJ, MO, IL, PA, NC. TX, TN, WA, ID, UT, WV, MS. CA, AL, MA. GA, LA and OK.
- Date initiated
- 2014-02-19
- Date posted
- 2014-04-03
- Location
- Somerville, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROCEED SURGICAL MESH (K060713) | ETHICON, Inc. | 2006-05-25 |