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Completed

Stradi 4500 - contains Devon Light Glove Used during surgery

FDA Recall Z-2020-2015 · Posted 2015-07-07

Recalling FirmStradis Healthcare, LLC.
Recall StatusCompleted
Product CodeLRO
Date Initiated2015-04-20
Product Quantity1

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.

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