FDAClass IIJune 22, 2016

Small Patient ECC Pack recall: Endotoxin

Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile…

Why was Small Patient ECC Pack recalled?

Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.

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?

Lot/batch No: 3000003260, Part number 701050175

Product
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile…
Recalling firm
Datascope Corporation
Quantity
17 units
Distribution
US in the state of GA
Recall date
June 22, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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