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

Recall Insight

This FDA Devices action (record #Z-0940-2013) was formally reported on March 20, 2013, with the manufacturer initiating the action on February 25, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Symbios Medical Products, LLC is listed as the recalling firm, operating out of Indianapolis, IN. Federal records indicate 458 units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.