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Na 1C8732

by Baxter International Inc. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00085412079530 UDI-DIDate24 Sep 2016ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

10 recalls · FDA

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

    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 via K993120, on the same 510(k)
    • Terminated Z-1178-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003
    • Terminated Z-1162-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003 via K993120, on the same 510(k)
    • 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 marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID

Trade Name
Na
Generic Name
Blood transfusion set, non-exchange
Model / Ref / Catalog
1C8732
Primary DI / UDI-DI
00085412079530
510(k) Number
FDA Product Code
BRZ
GMDN Term
Blood transfusion set, non-exchange
Device Class
Class II
Regulation Number
880.5440
Commercial Distribution
In Commercial Distribution

Related devices

Category: Blood transfusion set, non-exchange

Cleared under the same submission (K993120)

Show all (12)

Other devices from Baxter International Inc.

See all devices from Baxter International Inc. →

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