Reported Jan 22, 2014 · Terminated
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421.…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration)
- Universal Product Number (UPN)M00561421
- Distributed byBoston Scientific, Natick, MA
- Manufactured byHorizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses
- Lot codes and dates
- Lot Numbers
H13061102H13061103H13061104H13062401H13082603
- Lot Numbers
- Amount recalled
- 620 eaches
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Sterility of device may be compromised due to lack of pouch seal integrity
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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