—#143540

Product

Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA product code: FYA — Gown, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K971920
Affected lot / code info: LOTS: SL15174 (150518822) 31-MAY-16 SL15176 (150317997) 31-MAR-16 SV15168 (150418241) 30-APR-16 SV15168 (150117022) 31-MAR-16 SL15180 (150418241) 30-APR-16 SL15209 (150720052) 31-JUL-16 SL15210 (150720052) 31-JUL-16 SL15218 (150720052) 31-JUL-16 SL15219 (150720052) 31-JUL-16 SL15222 (150720052) 31-JUL-16 SL15246 (150820337) 31-AUG-16 SL15251 (150820337) 31-AUG-16 SL15252 (150820337) 31-AUG-16

Why it was recalled

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Root cause (FDA determination)

Packaging

Action the firm took

Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

Distribution pattern: Distributed only in Puerto Rico.

Timeline

Recall initiated: 2016-01-07
Posted by FDA: 2016-04-14
Terminated: 2017-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143540. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.