The Recall Desk
HighFDA (Devices)·Z-1496-2013·Announced 2013-06-12

Stryker T4 Zipper Toga Recalled for Potential Sterile Barrier Breach

Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging during the second and third years of shelf life.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a potential breach in the sterile barrier of a medical device, which poses a risk of harm (infection) even though no injuries have been reported yet, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 334,520 units (33,452 boxes) of Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O. The product is a single-use protection system intended to protect patients, healthcare personnel, and operating room personnel against contamination and exposure to infectious bodily fluids. The units were distributed nationwide in the United States.

The recall was initiated based on accelerated aging tests for the product packaging. These tests, which used high heat to accelerate the aging process, indicated a potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap. This potential breach is associated with the second and third year of the product's shelf life. Stryker is currently conducting additional testing and assessing the product.

Healthcare facilities and consumers should check their inventory for the specific product codes listed in the recall notice. If the product is found, it should be removed from use and returned to Stryker or the distributor in accordance with the recall instructions.

The recalled product

Product
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; 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 tr
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Drapes
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)

  • 1005097
  • 1009205
  • 1011294
  • 1102105
  • 1104268
  • 1106463
  • 1108633
  • 1109857
  • 1005098
  • 1009219
  • 1012313
  • 1102109
  • 1104305
  • 1106465
  • 1108648
  • 1109812
  • 1005104
  • 1008192
  • 1011281
  • 1102119

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 →

Related recalls

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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Same hazard · sterile barrier breach

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