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Moderate riskFDA DeviceClass II

Boston Scientific AMS 700 extenders recalled for possible wrong size

Boston Scientific is recalling certain AMS 700 CX/LGX Rear Tip Extenders labeled 0.5 cm. The package may contain a different size than the label shows, and some packages labeled 0.5 cm may contain a 1.5 cm extender. The notice reports no injuries.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

  1. Set aside any affected lots and contact Boston Scientific before using them, since these are implant components.
  2. Check the lot number on the package against these lots: 1100949284, 1100949288, 1100949293, 1100949299, 1100949301, 1100949322, 1100949328 (batch 39046410).
  3. Also check the package GTIN against 00878953004044 (primary) or 00878953008981 (unit of use).
  4. The notice doesn't say how to get a replacement; contact Boston Scientific directly.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
AMS 700 CX/LGX Rear Tip Extenders (RTEs), Snapcone, CX/LGX, 0.5 cm. UPN: 72404320.
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

Details

Units affected
7 units
Illnesses reported
None reported
Manufactured in
100 Boston Scientific Way, Marlborough, Massachusetts, United States
Classification
Class II
Recall number
Z-0396-2027

In the FDA's words

Description
AMS 700 CX/LGX Rear Tip Extenders (RTEs), Snapcone, CX/LGX, 0.5 cm. UPN: 72404320. Potential for the Rear Tip Extender (RTE) size contained within the package to differ from the size identified on the product labeling. Certain packages labeled as containing a 0.5 cm RTE may contain a 1.5 cm RTE. UPN: 72404320. Primary GTIN: 00878953004044. Unit of Use GTIN: 00878953008981. Batch Number: 39046410. Lot Numbers: 1100949284, 1100949288, 1100949293, 1100949299, 1100949301, 1100949322, 1100949328. Distribution: Worldwide - US Nationwide distribution in the states of CA, NC, PA, TX, UT, WI and the country of France. Affected quantity: 7 units
Hazard
Potential for the Rear Tip Extender (RTE) size contained within the package to differ from the size identified on the product labeling. Certain packages labeled as containing a 0.5 cm RTE may contain a 1.5 cm RTE.

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