Datascope Recalls Pediatric Cardiopulmonary Bypass Tubing Kits Due to Valve Defect
Datascope Corporation is recalling 27 pediatric cardiopulmonary bypass tubing kits because the over-pressure safety valve may fail to allow flow.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 where a mechanical failure could prevent necessary flow during a critical procedure, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Datascope Corporation is recalling 27 units of the Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041. The recall is due to a potential defect where the over-pressure safety (OPS) valve in the tubing kits may not allow flow through.
The affected products are sterile, non-pyrogenic devices intended for single use in procedures requiring extracorporeal support for up to six hours. The kits consist of tubing and connectors with connected oxygenators, reservoirs, filters, and other cardiopulmonary bypass components.
The 27 units were distributed to facilities in Iowa and Florida. The recall is classified as Class II by the FDA. Users should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The…
- Manufacturer
- Datascope Corporation
- Affected units
- 27
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)
- UDI 0607567203600
Distribution
Part of a larger recall action
This product is one of 3 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.
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