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Ethicon, Inc. recalls Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used f
Recalled April 9, 2014 · FDA recall Z-1329-2014 · Ethicon
Hazard
The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination. · FDA Class II
Units
223 units
Sold at
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.
Description
The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
Product
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Manufacturer(s)
Ethicon, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →