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FDA Medical Device Recalls (openFDA)

B. Braun Medical, Inc.: Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.

Recall number
Z-2409-2008
Recalling firm
B. Braun Medical, Inc.
Product
Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.
Status
Terminated
Initiated
2008-06-30
Posted
2008-09-23
Terminated
2009-05-05
Reason
incorrect burette was packaged with the product
Root cause
Mixed-up of materials/components
Action
The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance.
Quantity
840 units
Distribution
Nationwide.
Lot, serial or model codes
Lot number 60998903 exp 3/31/2013
510(k) numbers
["K904518","K921860"]
PMA numbers
not on file
Product code
FRN
Firm FEI
2523676
Firm city
Allentown
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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