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Baxter 2C7627

by Baxter Healthcare Corp GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00085412004136 UDI-DIDate24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

10 recalls · FDA

    • Terminated Z-0193-05 FDA Unclassified (pre-2012) initiated 28 Apr 2004 on shared 510(k) K993120

    Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.

  • 9 recalls, same reason

    • Terminated Z-1161-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003 on shared 510(k) K993120
    • Terminated Z-1178-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003
    • Terminated Z-1162-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003 on shared 510(k) K993120
    • Terminated Z-1160-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003
    • Terminated Z-1175-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003
    • Terminated Z-1172-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003
    • Terminated Z-1171-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003
    • Terminated Z-1177-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003
    • Terminated Z-1176-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003

    There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

GUDID

Trade Name
Baxter
Generic Name
Blood transfusion set, non-exchange
Model / Ref / Catalog
2C7627
Primary DI / UDI-DI
00085412004136
510(k) Number
FDA Product Code
BRZ
GMDN Term
Blood transfusion set, non-exchange
Device Class
Class II
Regulation Number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood transfusion set, non-exchange

Cleared under the same submission (K993120)

Show all (12)

Other devices from Baxter Healthcare Corp

See all devices from Baxter Healthcare Corp →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No