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Z-3133-2017 Class II Terminated

Recalled by Baxter Healthcare Corp — Mountain Home, AR

FDA device recall Z-3133-2017 was initiated by Baxter Healthcare Corp on September 1, 2017 and is designated Class II. Reason for recall: The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set w… The recall status is terminated (terminated August 27, 2019). Affected quantity: 164,700 units.

Recall Details

Product Type
Devices
Report Date
September 20, 2017
Initiation Date
September 1, 2017
Termination Date
August 27, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
164,700 units

Product Description

Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479

Reason for Recall

The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.

Distribution Pattern

nationwide, Canada

Code Information

Lot numbers: H16G28107, H16H01086, H16H04114, H16H09063, H16H13032, H16H19112, H16H26034, H16H30010, H16I02017, H16I06018, H16I08071, H16I12016, H16I14103, H16I16066, H16I19060, H16I21058, H16I23047, H16I26065, H16I30091, H16J03014, H16J05035, H16J07015, H16J09078, H16J11132, H16J14011, H16J16057, H16J18046, H16J20109, H16J22063, H16J24127, H16J26072, H16J28128, H16J30058, H16K01057, H16K03079, H16K05041, H16K07054, H16K08086, H16K10090, H16K28027, H16K30015, H16L04034, H16L11039, H16L15105

Other recalls by Baxter Healthcare Corp

  • Z-0370-2017 Class II — GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1106 (October 12, 2016)
  • Z-0670-2017 Class II — sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum In (September 28, 2016)
  • Z-0671-2017 Class II — Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infus (September 28, 2016)
  • Z-0672-2017 Class II — V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spec (September 28, 2016)
  • Z-2533-2016 Class II — Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product (June 24, 2016)
  • Z-2049-2016 Class II — PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy (May 23, 2016)
  • Z-1839-2016 Class II — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular re (May 12, 2016)
  • Z-1840-2016 Class II — COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular re (May 12, 2016)
  • Z-1838-2016 Class II — COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular rec (May 12, 2016)
  • Z-1627-2016 Class II — GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752 (April 21, 2016)

FDA data resources