Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
B Braun Medical Inc · Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
Open FDA's page for this record- Cfres ID
- 221832
- Product res number
- Z-3089-2026
- Event date initiated
- 2026-08-04
- Event date posted
- 2026-09-02
- Recall status
- Open, Classified
- Res event number
- 99550
- Product code
- FPA
- Product description
- Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
- Code info
- Lot Code: Model No 456025, UDI-DI 04046964183638, Lot Numbers 0062062778 and 0062062779
- Firm FEI number
- 2521402
- Recalling firm
- B Braun Medical Inc
- Address 1
- 824 12th Ave
- City
- Bethlehem
- State
- PA
- Postal code
- 18018-3524
- Additional info contact
- Allison longenhagen 001-484-2408373
- Reason for recall
- Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
- Root cause description
- Under Investigation by firm
- Product quantity
- 25850
- Distribution pattern
- 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.
- 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.
- K numbers
- K942988
- Harmonized identifiers (openFDA)
- Device name
- Set, Administration, Intravascular
- Medical specialty description
- General Hospital
- Regulation number
- 880.5440
- Device class
- 2
- K number
- K931377, K781186, K020544, K123344, K830258, K221069, K180843, K892429, K884264, K212262, K891176, K242126, K864296, K153293, K994429, K781190, K041490, K791173, K843463, K760103, K771271, K941453, K030385, K964439, K170002, K882798, K080665, K984441, K992266, K852361, K060488, K001423, K171117, K964067, K990288, K974589, K954813, K143234, K013394, K023469 +1,135 more
- Registration number
- 3003310007, 3018507299, 3003678543, 3005609751, 3013162291, 3047706961, 2029275, 3004111573, 3016096098, 3009882464, 3004122598, 1220973, 3004143450, 3017509841, 2032098, 3006891665, 1319211, 3010872792, 3003512059, 9610993, 8021079, 3036978618, 9610847, 3004519921, 9681572, 3009746425, 2024024, 3019004087, 3011642792, 3020417125, 1526611, 9614279, 3007007790, 1000523114, 1647137, 3008733163, 3012552122, 3003674698, 1061124, 3014246639 +391 more
- FEI number
- 3003310007, 3018507299, 3003678543, 3005609751, 3013162291, 3047706961, 3003081151, 3004111573, 3016096098, 3009882464, 3004122598, 3001665800, 1220973, 1000518731, 1000112877, 3008002452, 1000160458, 3004143450, 3017509841, 3006891665, 3003886545, 1319211, 3002806588, 3001570557, 3010872792, 3003512059, 3005846326, 1000174591, 3036978618, 3000215273, 3009746425, 2024024, 3019004087, 3011642792, 3020417125, 1526611, 3007007790, 1000523114, 3008733163, 3012552122 +391 more