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FDA (Device enforcement)Recalled 2017-12-18closedclass ii

Johnson & Johnson Consumer, Inc.: Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)

Is my product affected?

Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)

  • UPC 381371161508

Check against the official notice below — it lists the full affected range.

What happened

Johnson & Johnson Consumer Inc. is voluntarily recalling select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps, and BAND-AID Brand First Aid Products HURT-FREE Wraps products distributed nationally in the U.S. The products are being recalled because their labeling incorrectly states they are not made with natural rubber latex. The company recently became aware that natural latex was actually used as a base ingredient in the early-stage manufacturing process, though the latex used has reduced allergic protein content.

Consumers who have purchased these products with lot code 111615000 381371161508 or 103813711615050000 were affected by this recall. The record does not specify what action consumers should take regarding recalled products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH¿ Self-Adhering Sports Wraps, BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wraps and BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.

Details from the source

Reason for recall: Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH¿ Self-Adhering Sports Wraps, BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wraps and BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex. Distribution: Nationally Lot/code info: 111615000 381371161508 103813711615050000

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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