Recalls / —

—#200956

Product

Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014

FDA product code

FNY — Basin, Emesis

Device class

Class 1

Medical specialty

General Hospital

Affected lot / code info

a) REF '89-5014, GTIN 50749756217908 (cs), 00749756217903 (unit) Lot Numbers: 58770294

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 #200956. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.