The Recall Desk
SevereFDA (Devices)·Z-1716-2018·Announced 2018-05-16

Datascope Recalls Custom Tubing Packs Due to Potential Seal Separation

Datascope is recalling 22 units of BEQ-TOP 33700 ECC 3/8" PACK custom tubing kits because a seal defect may cause balloon collapse and reduced blood flow.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a critical life-support device (ECMO circuit) that could cause a drop in blood flow, meeting the criteria for a Severe rating.

Plain-English summary

Datascope Corporation is recalling 22 units of the BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating (Catalog No. 701053845). The affected lots are 3000056811, 3000063949, and 3000067795. These products were distributed to accounts in Alabama, Arkansas, California, the District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas, and Washington.

The recall was initiated because the Better Bladder device included in some of these custom tubing kits may experience seal separation from the housing. This defect allows air to enter the housing, which can cause the balloon to collapse. If the balloon collapses, it may increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.

Healthcare facilities and users should stop using the affected tubing packs immediately and contact Datascope Corporation for instructions on how to return the products. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
Manufacturer
Datascope Corporation
Category
Medical Device — ECMO / Extracorporeal Circulation
Hazard
Affected units
22

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot 3000056811
  • 3000063949
  • 3000067795

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 28 recalled by Datascope Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

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