Bd Switzerland Sarl: Set, Administration, Intravascular

Recall Summary Medline shipped engineering sample IV gravity sets (catalog number SAM2461) labeled "Not for Human Use" to customers in Illinois. These samples were not intended for patient use and should not have been distributed commercially. This is a Class II recall affecting products distributed in Illinois only.

Recalling firm

BD SWITZERLAND SARL

Product

MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use

Reason

Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.

Classification

Class II

Category

medical device recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-06-04

Status

Open, Classified

Areas affected

IL

Distribution

U.S.: IL O.U.S: N/A

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0076569d-c5fe-4ded-a28f-3d4d25effa4e