Device product
Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack culture collection and industrial surfaces
Z-1521-2014
Product summary
- Event
- Event 67786
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7430
- Official record key
device-enforcement:Z-1521-2014
Official wording
Reason: A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab.
Code information: all lots of article nos. 14-959-77, 14-959-78, 14-959-79, 14-959-81, 14-959-82, lots 60151, 61513, 61933, 62768, 63055, 60752, 61324, 62195, 63224, 60752, 62195, 61866, 62546, 8710, with expiration dates August 2014 through October 2015
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab.