Medical Device Recall: Z-0034-06

FDA Recalls dataset · Firm: Stryker Instruments Div. of Stryker Corporation · Status: Terminated

Recall Action Class: N/A Date Initiated: 2005-07-22 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0034-06.

Recall Res Number
Z-0034-06
Recalling Firm / Manufacturer
Stryker Instruments Div. of Stryker Corporation
FEI Number
1811755
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2005-07-22
Date Posted
2005-10-12
Date Terminated
2006-02-15
Product Code
LXC
Event Number
32842
Product Quantity
473
Product Description Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
Reason for Recall The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
Action Details Consignees were notified by recall letter dated August 5, 2005 to locate the affected serial numbers and to return the product to the firm.
Distribution Pattern Nationwide, Argentina, Australia, Canada, Costa Rica, England, France, Germany, Hong Kong, India, Indonesia, Japan, Netherlands, New Zealand, South Africa, Spain, Sweden, Switzerland, Taipei, Turkey and United Arab Emir.
Code Information / Serial Numbers Serial numbers 0428702183 through 0518008193.

Related Establishments / Registrations

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