Datascope Small Patient ECC Pack Recalled for Excess Endotoxin
Datascope Corporation is recalling 17 units of Small Patient ECC Packs due to endotoxin levels exceeding regulatory limits. The affected units were distributed in Georgia.
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 medical device with a contamination hazard (endotoxin) exceeding regulatory limits. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Datascope Corporation is recalling 17 units of the Small Patient ECC Pack (REF BEQ-TOP 24100). The recall was initiated because the product was identified as possessing a level of endotoxin that exceeded regulatory limits.
The affected product is a medical device used in open heart surgery to connect patients to heart-lung machines for blood oxygenation. The specific units involved are identified by Lot/batch No. 3000003260 and Part number 701050175. These units were distributed in the state of Georgia.
Consumers and healthcare facilities should stop using the affected tubing sets and contact Datascope Corporation for further instructions or a replacement.
The recalled product
- Product
- 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 surg
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Surgical Tubing
- Hazard
- Affected units
- 17
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 (2)
- Lot/batch No: 3000003260
- Part number 701050175
Distribution
Distributed in 1 state:
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