—#200959

Product

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

FDA product code: OEQ — Angiography/Angioplasty Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected 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

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2023-05-30
Posted by FDA: 2023-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200959. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.