Datascope Recalls Custom Tubing Packs Due to Assembly Error
Datascope Corporation is recalling 21 custom tubing packs with Bioline coating due to a reported assembly error on the oxygenator line.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used in open heart surgery with a reported assembly defect. While no injuries are explicitly reported in the source text, the potential for harm in a critical surgical context aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Datascope Corporation is recalling 21 kits of Custom Tubing Packs with Bioline Coating (Part Number 709000058, Lot 3000033848). These medical devices are used in open heart surgery to connect patients to heart-lung machines for blood oxygenation and carbon dioxide removal. The affected units were distributed to the state of California.
The recall was initiated after a complaint received on January 1, 2017, reported that the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and clear cap remained on the center port. This assembly error could potentially affect the function of the extracorporeal perfusion circulation system during surgery.
Healthcare facilities that received these specific tubing packs should stop using them and contact Datascope Corporation for instructions on return or replacement. Consumers are not expected to have these products in their homes, as they are specialized medical devices used in surgical settings.
The recalled product
- Product
- 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-sterili
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Surgical Tubing
- Affected units
- 21
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 (1)
- Lot number 3000033848
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Datascope Corporation
See all →- HighLINEAR Intra-Aortic Balloon Catheter Recalled for Incorrect Volume Labeling
FDA (Devices) · 2022-11-02
- HighMEGA Intra-Aortic Balloon Catheter Recalled for Undersized Dilator
FDA (Devices) · 2022-09-14
- HighUndersized Dilator in Balloon Catheter Insertion Kit Recalled
FDA (Devices) · 2022-09-14
- HighFDA Recalls Sensation Plus Catheter for Undersized Dilator Manufacturing Defect
FDA (Devices) · 2022-09-14
- HighDatascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2020-09-02
Same hazard · assembly error
See all →- ModerateKnee fusion nail components recalled over a locking screw inserted backwards
FDA (Food) · 2025-12-17
- HighMiniaturized TEE probes recalled over reversed articulation from assembly error
FDA (Devices) · 2025-10-15
- ModeratePhasor neurosurgical drills may have a reverse battery orientation
FDA (Devices) · 2025-08-06
- SevereMedline Fluid Delivery Sets incorrectly assembled with wrong drip chamber
FDA (Devices) · 2025-01-22
- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03