—#139866

Product

DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: TOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: REF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436

Why it was recalled

Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.

Root cause (FDA determination)

Other

Action the firm took

DeRoyal initiated their recall on 08/31/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors were asked to put the product in quarantine, place the provided labels on the products and complete and return the spreadsheet of how many they labeled. They were asked to return the spreadsheet even if they did not have inventory. Hospitals were provided with labels to affix to the kits with direction to discard the recalled component and notice of destruction forms to be completed and returned.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: SC, FL, OH, NJ, OK, MN, AR

Timeline

Recall initiated: 2015-08-31
Posted by FDA: 2015-11-06
Terminated: 2016-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139866. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.