PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol Prep Pads, packaged in the Al

FDA device recall Z-0188-2012 · posted 2011-11-16 · Terminated

Recall details

Recalling firm

Alere San Diego

Reason for recall

Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus.

Action taken

Alere sent a recall notification letter dated October 6, 2011, and Verification Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use an alternate prep pad that is not involved with the PDI recall, or use a sterile gauze pad with isopropyl alcohol. If customers purchase alcohol pads from a store or pharmacy, customers can confirm with their pharmacist that the pads they are purchasing are not associated with the PDI recall. INRatio/INRatio2 kits at Alere are currently being reworked to include a sterile PDI alcohol pad. Customers were instructed to complete and FAX the enclosed Verification Form within 10 days to confirm their receipt of the notice and to indicate the number of discarded/required replacement alcohol prep pads. Customers with questions about INRatio/ INRatio 2 were instructed to consult their healthcare provider, or call Alere Technical Service at 877-866-5313 (24 hours a day, 7 days a week).

Root cause

Material/Component Contamination

Status

Terminated

Product code

LKB

Quantity affected

Estimated 14,248 Total units

Distribution

Nationwide Distribution

Date initiated

2011-10-11

Date posted

2011-11-16

Date terminated

2012-02-29

Location

San Diego, CA

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