Recall Z-0013-2012
Convatec Inc. · initiated June 22, 2011
Product
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.
Codes / lots: Lot 1C00776 No 510K since this is Class I exempt.
Reason for recall
Post-operative kits 57 mm may contain 70 mm pouches.
FDA-determined cause: Labeling mix-ups
Action taken
The firm, ConvaTec, sent a "MEDICAL DEVICE RECALL" letter dated June 22, 2011 via UPS 2nd day air to all customers and sales representatives that received product. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop distributing and quarantine the recalled lot; perform a count of recalled product currently in inventory; complete and return the Recall Response Form via fax to (908) 904-2120 or mail to 200 Headquarters Park Drive, Skillman, New Jersey 08558; return the Recall Response Form even if no recalled product is in inventory; call the toll free number 1-800-582-6514 for return instructions and RGA number-(recall product must be returned in a separate container from any other product returns); mark all return shipments "Recalled Product" and provide supplied RGA number, and forward this letter to customers, if they distributed the product. Should you have any questions, call 1-800-582-6514.
Details
- Recall number
- Z-0013-2012
- Initiated
- June 22, 2011
- Posted by FDA
- October 5, 2011
- Terminated
- January 11, 2012
- Product code
- EXB – Collector, Ostomy
- Quantity
- 283 units
- Distribution
- Nationwide distribution: AL, AZ, CA, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX and UT.
- Recalling firm
- Convatec Inc., Skillman, NJ