Medical Device Recall: Z-0013-2012

FDA Recalls dataset · Firm: Convatec Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2011-06-22 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0013-2012.

Recall Res Number
Z-0013-2012
Recalling Firm / Manufacturer
Convatec Inc.
FEI Number
3011987967
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2011-06-22
Date Posted
2011-10-05
Date Terminated
2012-01-11
Product Code
EXB
Event Number
59952
Product Quantity
283 units
Product Description Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.
Reason for Recall Post-operative kits 57 mm may contain 70 mm pouches.
Action Details 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.
Distribution Pattern 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.
Code Information / Serial Numbers Lot 1C00776 No 510K since this is Class I exempt.

Related Establishments / Registrations

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