—#200957

Product

Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478

FDA product code: KDD — Kit, Surgical Instrument, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: a) REF 89-10640, GTIN 50749756367740 (cs), 00749756367745 (unit), Lot Numbers: 58737945; b) REF 89-10901, GTIN 50749756380244 (cs), 00749756380249 (unit), Lot Numbers: 58820749; c) REF 89-1924, GTIN 50749756216864 (cs), 00749756216869 (unit), Lot Numbers: 58746227; d) REF 89-7133, GTIN 50749756736744 (cs), 00749756736749 (unit), Lot Numbers: 58789323; e) REF 89-9134, GTIN 50749756911332 (cs), 00749756911337 (unit), Lot Numbers: 58701336; f) REF 89-9478, GTIN 50749756926909 (cs), 00749756926904 (unit), Lot Numbers: 58738454

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 #200957. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.