Shent USA, Inc.: Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm).

Agency Publication Date: August 6, 2021

Affected Products

Product: Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope

Lot Code: 020377208

Lot Numbers:

Code

Product: Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope

Lot Code: D20177226-19

Lot Numbers:

Code

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88136

Status: Resolved

Manufacturer: Shent USA, Inc.

Manufactured In: United States

Units Affected: 2 products (47 units (20 US; 27 OUS); 85 units OUS)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope

Lot Code: 020377208

Lot Numbers:

Code

Product: Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope

Lot Code: D20177226-19

Lot Numbers:

Code