CLASS II Device recall · Reported 22 Jun 2016 · FDA Enforcement Report
Small Patient ECC Pack recalled by Datascope
Datascope is recalling Small Patient ECC Pack, distributed in Georgia. The recall was initiated on 9 May 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2002-2016
- FDA event ID
- 74341
- Recalling firm
- Datascope, Fairfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 May 2016
- FDA classified
- 15 Jun 2016
- Reported
- 22 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 9 May 2016 | Recall initiated by company | |
| 15 Jun 2016 | Classified by FDA | +37 days |
| 22 Jun 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours
Where it was distributed
US in the state of GA
Questions about this recall
Is Small Patient ECC Pack recalled?
Yes. Datascope recalled Small Patient ECC Pack on 9 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2002-2016.
Why was it recalled?
Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
Which lots are affected?
Lot/batch No: 3000003260, Part number 701050175
Where was it sold?
US in the state of GA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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