DeRoyal Industries Inc: Medical Device Recall in 2015 - (Recall #: Z-0241-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 31, 2015

Date Posted: November 18, 2015

Recall Number: Z-0241-2016

Event ID: 72098

Reason for Recall:

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.

Status: Terminated

Product Quantity: N/A

Code Information:

REF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436

Distribution Pattern:

SC, FL, OH, NJ, OK, MN, AR

Voluntary or Mandated:

Voluntary: Firm initiated