—#161247

Product

Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K842648
Affected lot / code info: Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903

Why it was recalled

DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.

Root cause (FDA determination)

Process change control

Action the firm took

The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 01/22/18 to its Consignees on 1/22/18 by overnight mail. The firm sent a follow-up "URGENT! RECALL NOTICE" letter dated 1/29/18. The letters described the product, problem and actions to be taken. The Consignees were instructed to identify affected products; place in quarantine; complete and return the Notice of Return Form, even if they no longer held any affected product, to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than 3/1/18, and return any product they held in stock. If you have further distributed these products, notify your customers of this recall. If you have questions or need assistance with the recall, please contact Regulatory Recall Coordinator and Quality Projects Manager at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to: NY

Timeline

Recall initiated: 2018-01-22
Terminated: 2020-08-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161247. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.