Medical Device Recall: Z-0027-2007

FDA Recalls dataset · Firm: N/A · Status: Terminated

Recall Action Class: N/A Date Initiated: 2006-08-09 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0027-2007.

Recall Res Number
Z-0027-2007
Recalling Firm / Manufacturer
N/A
FEI Number
2110898
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2006-08-09
Date Posted
2006-10-11
Date Terminated
2007-05-25
Product Code
JOJ
Event Number
36180
Product Quantity
6248 cases (4 boxes/case)
Product Description 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Reason for Recall 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.
Action Details The firm initiated a recall of the Comply 1248 product made with the discrepant material. Customer letters were sent on August 14, 2006. Letters notified customers of problem and instructed them to discontinue distribution or use of the product. Then to return all affected product to them.
Distribution Pattern Nationwide.
Code Information / Serial Numbers Lot number 2006-12 AA through 2008-06 AB.

Related Establishments / Registrations

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

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