Recall Z-2300-2012— SRI Surgical
Class II · Terminated
Class II FDA medical device recall by SRI Surgical, initiated 2008-07-16, terminated 2012-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.. Reason: Distribution of a product that did not meet specifications. (labeling error).
- Recalling firm
- SRI Surgical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2008-07-16
- Terminated
- 2012-09-10
- Firm location
- Tampa, FL, United States
Product description
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.
Reason for recall
Distribution of a product that did not meet specifications. (labeling error)
Data sourced from openFDA. This site is unofficial and independent of the FDA.