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Terminated

PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings

FDA Recall Z-1036-2016 · Posted None

Recall StatusTerminated
Product CodeFRO
Date Initiated2016-02-03
Date Terminated2016-06-28
Product Quantity9 cases (180 kits)

Reason for Recall

Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling

Firm Action

Medical Action Industries, Inc. sent an Urgent Medical Device Recall letter dated February 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine all product subject to this recall. Consignees were also instructed if product was further distributed to identify their consignees and notify them at once of this product recall. Recalled product should be returned to Medical Action Industries for credit or replacement by contacting [email protected] . Consignees were asked to complete and return the enclosed response form. Consignees with questions were instructed to call 828-338-7630.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide distribution to MO, NE and TX .

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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