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Z-1490-2013 Class II Terminated

Recalled by Stryker Instruments Div. Of Stryker Corporation — Portage, MI

FDA device recall Z-1490-2013 was initiated by Stryker Instruments Div. Of Stryker Corporation on May 23, 2013 and is designated Class II. Reason for recall: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for… The recall status is terminated (terminated Apr 14, 2014). Affected quantity: 48,040 units, ( 4804 boxes).

Recall details

Product Type: Devices
Report Date: Jun 12, 2013
Initiation Date: May 23, 2013
Termination Date: Apr 14, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 48,040 units, ( 4804 boxes)

Product description

Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Reason for recall

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Distribution pattern

USA Nationwide Distribution

Code information

1005105, 1010244, 1101004, 1104289, 1107568, 1005119, 1010261, 1101030, 1104324, 1108625, 1006129, 1011276, 1101047, 1105390, 1108672, 1006140, 1011296, 1102073, 1105355, 1109730, 1007151, 1012314, 1102127, 1106431, 1109782, 1007163, 1012337, 1102131, 1106467, 1109858, 1009213, 1012346, 1104253, 1107515.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1490-2013
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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