Stradis Healthcare Recalls Breast Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling nine Breast Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
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 surgical medical device component (gloves) that is being recalled by the primary manufacturer. While no specific injuries are reported in the text, the use of recalled components in surgery presents a risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stradis Healthcare, LLC. is recalling nine units of Breast Packs that contain Devon Light Gloves. These packs are used during surgery. The recall is being conducted because the manufacturer of the Devon Light Glove component, Medtronic, has recalled the gloves.
The affected products were distributed nationwide in the United States to specific states including Alabama, Alaska, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Mexico, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington. The products were also distributed to Canada and Dubai.
The specific pack codes involved in this recall are 693-196, 693-188, 693-166, 693-112, and 888-2583. Consumers and healthcare facilities should check their inventory for these specific pack codes and stop using the affected products immediately.
The recalled product
- Product
- Breast Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Affected units
- 9
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 (5)
- Pack 693-196
- 693-188
- 693-166
- 693-112
- 888-2583
Distribution
Part of a larger recall action
This product is one of 51 recalled by Stradis Healthcare, LLC. 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 51 products in this recall →Related recalls
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