The Recall Desk
ModerateFDA (Devices)·Z-0724-2017·Announced 2016-12-14

Halyard C-Section Drapes Recalled for Manufacturing Variation

Halyard Health is recalling specific lots of C-Section drapes because a manufacturing variation may prevent the removal of coated release paper, inhibiting easy access to the surgical site.

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: The recall is classified as FDA Class II. The hazard is a manufacturing variation that impedes access to the surgical site, but the source text explicitly states no illnesses or injuries have been reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Halyard Health, Inc. is recalling 132 cases of Halyard C-Section Drapes, including both sterile and non-sterile versions with clear screens, pouches, and fenestrations. The affected products were distributed nationwide in the states of AL, FL, GA, IL, KS, MN, MO, NE, NJ, OH, PH, TN, VA, WI, and WY.

The recall is due to a manufacturing variation that may prevent the convenient removal of the coated release paper. This issue inhibits easy access to the surgical site. The source text does not report any illnesses, injuries, or deaths associated with this defect.

Healthcare facilities should identify the affected product codes and lot numbers listed in the recall notice and stop using these specific drapes. The source text does not provide specific consumer instructions beyond the identification of the affected lots.

The recalled product

Product
Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear S
Manufacturer
Halyard Health, Inc
Category
Medical Device — Surgical Drapes
Hazard
Affected units
132

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)

  • Product Code 44965 NS - Lot Numbers AC6174###
  • AC62266###
  • AC6229###
  • AC6243###
  • AC6252###
  • Product Code 44966 00 - Lot Numbers AC6146##L
  • AC6157##L
  • AC6177##L
  • AC6215##L
  • AC6221##L
  • AC6228##L
  • AC6245##L
  • AC6252##L
  • AC6258##L
  • AC6272##L
  • AC6277##L
  • Product Code 44967 NS - Lot Numbers AC6170###
  • AC6219###
  • AC6223###
  • AC625###

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

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