FDA (Devices) recall action 76994

Breg Inc recalled 8 products on 2017-05-10

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2017-05-10
Critical: 0
Units: 18,263

Why these products were recalled

They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

HighFDA (Devices)··2017-05-10
Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches
Breg Inc is recalling sterile dressings (P/N 02328) because a small percentage may have unsealed pouches, rendering them non-sterile.
Product
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be app
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ModerateFDA (Devices)··2017-05-10
Breg Inc Recalls Sterile Dressings Due to Potential Unsealed Pouches
Breg Inc is recalling approximately 2,609 sterile dressings because a small percentage may have unsealed pouches, rendering them non-sterile.
Product
Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied
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ModerateFDA (Devices)··2017-05-10
Breg Inc Recalls Knee Dressings Due to Unsealed Pouches
Breg Inc is recalling 2,609 units of Knee L/XL Dressings because some may have unsealed pouches, rendering them non-sterile.
Product
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be app
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ModerateFDA (Devices)··2017-05-10
Breg Inc Recalls Dressing Back P/N 09810 Due to Unsealed Pouches
Breg Inc is recalling 2,609 units of Dressing Back P/N 09810 because approximately 0.22% may have unsealed pouches, rendering them non-sterile.
Product
Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied i
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ModerateFDA (Devices)··2017-05-10
Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches
Breg Inc is recalling 2,609 sterile dressings because approximately 0.22% may have unsealed pouches, rendering them non-sterile.
Product
Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied
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ModerateFDA (Devices)··2017-05-10
Breg Inc Recalls Unsealed Sterile Dressings for Cold Therapy Pads
Breg Inc is recalling approximately 2,609 sterile dressings used with cold therapy pads because some may have unsealed pouches, rendering them non-sterile.
Product
Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be appli
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HighFDA (Devices)··2017-05-10
Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches
Breg Inc is recalling 2,609 units of Dressing Rect L (P/N 02428) because some may have unsealed pouches, rendering them non-sterile.
Product
Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied
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ModerateFDA (Devices)··2017-05-10
Breg Recalls If Hip Sterile Polar Dressings Due to Unsealed Pouches
Breg Inc is recalling 2,609 units of If Hip Sterile Polar Dressings because some may have unsealed pouches, rendering them non-sterile.
Product
If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion
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