DeRoyal Industries Inc: Medical Device Recall in 2023 - (Recall #: Z-2090-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183

Product Classification:

Class II

Date Initiated: May 30, 2023

Date Posted: July 12, 2023

Recall Number: Z-2090-2023

Event ID: 92445

Reason for Recall:

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Status: Ongoing

Product Quantity: 306 packs

Code Information:

a) REF 89-7102, GTIN 50749756734085 (cs), 00749756734080 (unit), Lot Numbers: 58806701; b) REF 89-7322, GTIN 50749756736171 (cs), 00749756736176 (unit), Lot Numbers: 58821231; c) REF 89-9183, GTIN '0749756904846 (cs), 00749756904841 (unit), Lot Numbers: 58741944

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated