ISSUE: Symbios Medical Products, LLC sent its
customers an "URGENT MEDICAL DEVICE RECALL" notification letter
detailing the reason for recall and products listed. The reason for the recall
is that the flow restrictor bead may become displaced from its fitting which
may permit solutions to flow at a higher rate than intended. This product may
cause serious adverse health consequences, including death. These kits were
distributed between Sept. 10, 2012 and Feb. 11, 2013. Refer to the Recall
Notice for a list of kit part numbers.
BACKGROUND: The Symbios Disposable Infusion Pump
Kit is a disposable, self-contained infusion system using an inflatable
elastomeric reservoir to mechanically provide percutaneous infusion of
prescribed solutions at a pre-set rate for post-operative pain management.
RECOMMENDATION: Customers are asked to: segregate
recalled product, complete verification form, indicate returned products on
verification form, obtain a returned goods authorization (RGA) number, and
package the returned products. Refer to the Recall Notice for details.
professionals and patients are encouraged to report adverse events or side
effects related to the use of these products to the FDA's MedWatch Safety
Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on
the pre-addressed form, or submit by fax to 1-800-FDA-0178
the MedWatch safety alert, including links to the Recall notice, at: http://www.fda.gov/
Source: U.S. Food and Drug Administration (FDA) (Accessed: 3/18/2013)