Medical Device Recall: Z-0027-04

FDA Recalls dataset · Firm: Instrumentation Laboratory Co. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-08-28 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0027-04.

Recall Res Number
Z-0027-04
Recalling Firm / Manufacturer
Instrumentation Laboratory Co.
FEI Number
1217183
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-08-28
Date Posted
2003-10-15
Date Terminated
2012-05-23
Product Code
LNW
Event Number
27163
Product Quantity
287 boxes
Product Description Lactate Disposable Membrane Caps Product Number: 0018108400
Reason for Recall Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.
Action Details Instrumentation Laboratories notified two (2) U.S. direct customers on August 28, 2003 by telephone, regarding Lot N30601. Follow-up phoning emphasizing significance of linearity problem (and additional involved lot N307 - for 1 affected customer) performed on September 3, 2003. Phone call followed with faxback acknowledging notification and disposition of remaining product lot(s). IL service also dispatched to customer sites on September 4, 2003. International Distributor Notices sent to IL Europe and IL Mexico on September 4, 2003. Product Information Bulletins circulated on September 3, 2003, to IL personnel worldwide.
Distribution Pattern IL, NY International: Italy, Mexico
Code Information / Serial Numbers US Distribution Lot Numbers: N307, Exp. 1/30/04  N30601, Exp 12/30/03 International Distribution: N30301 Exp 9/30/03 N30501 EXp 11/30/03 N306 Exp 12/30/03 N30604 Exp 12/30/03 N308 Exp 2/28/04

Related Establishments / Registrations

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