Small Patient ECC Pack BEQ-TOP 22301 — Class II medical device recall Z-1707-2018
Terminated recall by Datascope Corporation, reported 2018-05-16, distributed in AL, AR, CA, DC, FL, IL, LA, MO…. The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. S
| Recall number | Z-1707-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corporation, Fairfield, NJ, United States |
| Recall initiated | 2017-10-19 |
| Classified | 2018-05-08 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-04-24 |
| Distributed | AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, WA |
| Quantity | 1 |
| Reason classes | packaging |
| Lot numbers | 3000060036 |
| Model numbers | 701049513 |
Product
Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
Reason for recall
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1707-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.