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Recall Observatory FDA recall evidence

Device product

Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.

Z-1955-2013

June 05, 2013

Class II

Product summary

Firm
Fisher Scientific Co
Event
Event 65822
Status
Terminated
Classification
Class II
Quantity
1230
Official record key
device-enforcement:Z-1955-2013

Official wording

Reason: The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.

Code information: Product code # 14-959-81, lot #61513, expiration date: 2014-08, and lot 8710, expiration date 2014-08.

Distribution pattern: Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.

Field note

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