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FDA Medical Device Recalls (openFDA)

B Braun Medical Inc: Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025

Recall number
Z-3089-2026
Recalling firm
B Braun Medical Inc
Product
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Status
Open, Classified
Initiated
2026-08-04
Posted
2026-09-02
Terminated
not on file
Reason
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
Root cause
Under Investigation by firm
Action
Firm began notifying customers via letter on August 4, 2026. Customers were informed that the shipper label incorrectly identifies the expiration date as 31JAN2031. The correct expiration date is listed on the individual product blisters as 01NOV2028. Customers were instructed to cease use and quarantine affected product. Product is not to be destroyed. Impacted product is to be returned to the firm for credit or replacement.
Quantity
25850
Distribution
Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, IL, IN, LA, MA, MD, NC, NJ, NY, PA, TN, TX, VA, WA the country of Canada.
Lot, serial or model codes
Lot Code: Model No 456025, UDI-DI 04046964183638, Lot Numbers 0062062778 and 0062062779
510(k) numbers
K942988
PMA numbers
not on file
Product code
FPA
Firm FEI
2521402
Firm city
Bethlehem
Firm state
PA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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