FDAClass IIJanuary 16, 2013

Rigid Tip Suction Wand Non sterile bulk devices recall

Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as…

Why was Rigid Tip Suction Wand Non sterile bulk devices recalled?

California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.

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?

Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N

Product
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as…
Recalling firm
California Medical Laboratories Inc
Quantity
S112468N=1000 units, S120196N=1400 units, & S120197N=1200 units
Distribution
Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
Recall date
January 16, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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