Recall Z-1036-2016— Medical Action Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medical Action Industries Inc, initiated 2016-02-03, terminated 2016-06-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling.
- Recalling firm
- Medical Action Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-03
- Terminated
- 2016-06-28
- Firm location
- Arden, NC, United States
Product description
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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.