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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Coban SelfAdherent Wrap

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  Class 2 Device Recall 3M Coban SelfAdherent Wrap see related information
Date Initiated by Firm December 01, 2015
Create Date January 06, 2016
Recall Status1 Terminated 3 on May 24, 2016
Recall Number Z-0601-2016
Recall Event ID 72780
Product Classification Self-Adherent Wrap - Product Code FMP
Product 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Code Information Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton)
Recalling Firm/
Manufacturer		 3M Company - Health Care Business
3m Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144-0001
For Additional Information Contact 3M Customer Helpline
800-228-3957
Manufacturer Reason
for Recall		 Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe.
FDA Determined
Cause 2		 Process control
Action Consignees were sent via certified mail on 12/1/2015 a 3M letter dated November 25, 2015 and an emal on 12/5/2015 for the updated 3M "Urgent Medical Device" letter dated November 25, 2015. The letter was addressed to 3M Health Care Distributor. The letter described the problem, device involved in the recall and the action required. Advised consignees to quarantine the product, notify their customers and to complete and return the "Product Recall Form". Distributors were also provided with a "Customer" letter for distribution. For questions contact 3M Customer Helpline 1-800-228-3957.
Quantity in Commerce 167 cases (30 rolls/case)
Distribution US nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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