Reported Jun 12, 2013 · Terminated
Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time…
Symbios Medical Products, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Symbios Medical Products, LLC · 7301 Georgetown Rd. · Indianapolis, IN · 46268
Is this the product you have?
- Part 510031 Disposable Single Infusion Pump, quantity Includes
- TOTAL VOLUME
150mL2
- mL/hr continuous Delivery TimeApp. 72 hrs when filled to capacity Sterile EO
- found in the following GoPump KitsGoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 - BP, w/ Epidural Catheter, BIOPATCH GoPump Kit 510110, w/2.5" Fenestrated Catheter GoPumpKit 510110-BP, w/2.5" Fenestrated Catheter,BioPatch GoPumpKit 510350 w/ Epidural Catheter GoPump Kit 510350-BP w/ Epidural Catheter, BIOPATCH GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Lot 11-l 00106 to 2 Lot 12-101133 Kit 510042, lots 11-100251 to 13-100128 Kit 510042-BP 3 lot 12-101300 Kit 510110 4 lot 11-100664 Kit 510110-BP, Lots 11-100838 to 12-101560 Kit 510350, Lots 11-100353 to 12-100233 Kit 510350-BP 5 Lots12-100429 to 13-100047 Kit 510556-BP Lots 11-100779 to 12-101552 - Amount recalled
- 33, 543 in all sizes/ kits
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
Using this product could cause serious injury, illness or death — stop using it now.
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