Recall Z-0601-2016
3M Company - Health Care Business · initiated December 1, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Codes / lots: Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton)
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: Process control
Action taken
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.
Details
- Recall number
- Z-0601-2016
- Initiated
- December 1, 2015
- Terminated
- May 24, 2016
- Product code
- FMP – Protector, Skin Pressure
- Quantity
- 167 cases (30 rolls/case)
- Distribution
- US nationwide distribution.
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN