FDAClass IIApril 19, 2017

Custom Tubing Pack with Bioline Coating recall

Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use…

Why was Custom Tubing Pack with Bioline Coating recalled?

A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.

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 number 3000033848

Product
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use…
Recalling firm
Datascope Corporation
Quantity
21 kits
Distribution
US Distribution to the state of : CA.
Recall date
April 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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