GOPump Elastometric infusion PumpKit with/ and without accesssories… — Class I medical device recall Z-0940-2013
Terminated recall by Symbios Medical Products, LLC, reported 2013-03-20, distributed nationwide. Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, w
| Recall number | Z-0940-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Symbios Medical Products, LLC, Indianapolis, IN, United States |
| Recall initiated | 2013-02-25 |
| Classified | 2013-03-13 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2014-02-13 |
| Distributed | Nationwide (US) |
| Quantity | 458 |
| Lot numbers | 12-100601, 12-100983, 12-100984, 12-101028, 12-101045, 12-101096, 12-101097, 12-101103, 12-101110, 12-101125, 12-101130, 510401-BP, 510644 |
| Model numbers | 510076, 510112-BP, 510545-BP |
Product
GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management
Reason for recall
Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
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-0940-2013. 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.