FDAClass IIApril 20, 2016

Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH recall

Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures and…

Why was Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LOTS: SL15175 (150518789) 30-APR-16 SL15177 (150518789) 30-APR-16 SL15180 (150619314) 30-APR-16 SL15183 (150619314) 30-APR-16 SL15232 (150820305) 31-MAY-16 SL15233 (150820305) 31-MAY-16 SL15233 (150719845) 31-MAY-16 SL15243 (150719845) 31-MAY-16 SL15268 (150920814) 31-MAY-16

Product
Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures and…
Recalling firm
Customed, Inc
Quantity
5650
Distribution
Distributed only in Puerto Rico.
Recall date
April 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls