The Recall Desk
ModerateFDA (Devices)·Z-1494-2013·Announced 2013-06-12

Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach

Stryker is recalling T4 Toga pullovers because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall involving a potential sterile barrier breach. The hazard is theoretical based on accelerated aging tests, and no illnesses or injuries are reported, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Stryker Instruments Division of Stryker Corporation is recalling 21,660 units (2,166 boxes) of Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO. These single-use products are intended to protect patients, healthcare personnel, and operating room personnel against contamination and exposure to infectious bodily fluids. The products were distributed nationwide in the United States.

The recall is based on accelerated aging tests for the product packaging, which indicated a potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap. This potential breach could occur within the second and third year of the product's shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing the product.

Healthcare facilities should stop using the affected products and contact Stryker for further instructions. The affected lot codes are 1005105, 1009214, 1104308, 1006130, 1010260, 1104312, 1007152, 1012346, 1105378, 1007163, 1012303, 1106460, 1007164, 1101062, 1107542, 1008189, 1101063, 1108660, 1008188, 1102149, 1109760, 1009213, and 1103219.

The recalled product

Product
Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large 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
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Gowns
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1005105
  • 1009214
  • 1104308
  • 1006130
  • 1010260
  • 1104312
  • 1007152
  • 1012346
  • 1105378
  • 1007163
  • 1012303
  • 1106460
  • 1007164
  • 1101062
  • 1107542
  • 1008189
  • 1101063
  • 1108660
  • 1008188
  • 1102149

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 16 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

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