DeRoyal Industries Inc: 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

Hazard

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

Details from the source

Reason for recall: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Distribution: US Nationwide distribution. Quantity: 306 packs Lot/code info: 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

UPC codes

50749756734085, 00749756734080, 50749756736171, 00749756736176, 0749756904846, 00749756904841

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.