CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report
Custom Tubing Pack with Bioline Coating recalled by Datascope
Datascope is recalling Custom Tubing Pack with Bioline Coating, distributed in California. The recall was initiated on 16 Feb 2017 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-1769-2017
- FDA event ID
- 76518
- Recalling firm
- Datascope, Fairfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Feb 2017
- FDA classified
- 10 Apr 2017
- Reported
- 19 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 16 Feb 2017 | Recall initiated by company | |
| 10 Apr 2017 | Classified by FDA | +53 days |
| 19 Apr 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
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
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 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 heart-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. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
Where it was distributed
US Distribution to the state of : CA.
Questions about this recall
Is Custom Tubing Pack with Bioline Coating recalled?
Yes. Datascope recalled Custom Tubing Pack with Bioline Coating on 16 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1769-2017.
Why was it 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.
Which lots are affected?
Lot number 3000033848
Where was it sold?
US Distribution to the state of : CA.
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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