Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
FDA Recall Z-2010-2015 · Posted 2015-07-07
Recalling FirmStradis Healthcare, LLC.
Recall StatusCompleted
Product CodeLRO
Date Initiated2015-04-20
Product Quantity5
Reason for Recall
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Firm Action
Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to [email protected]. Customers with questions regarding return of the product should call 1-727-642--4124.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.