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FDAFebruary 16, 2017device

Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In op...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Terminated

Brands named

datascope

UPCs

00607567208230

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In op... — Recall Details · AllClear