Serious riskFDA DeviceClass I

Cardinal Health Presource IV kits recalled for performance issues

Cardinal Health 200, LLC is recalling Presource PBDS IV start kits that contain BD Alaris Pump Infusion Sets used with the BD Alaris Pump Module Model 8100. The kits contain infusion sets that were recalled for performance issues. The FDA has classified this as a Class I recall, its most serious category, and 221,554 kits are affected.

From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls

What to do

  1. Check kits in stock against the catalog and lot numbers listed in the notice, and set aside any that match.
  2. Contact Cardinal Health for next steps, because the notice does not specify a remedy.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) IV START LD KIT , CATALOG # IVS5342277; 2) IV START LD KIT , CATALOG # IVS5342276; 3) IV START LD KIT , CATALOG # IVS5342275; 4) IV START LD KIT , CATALOG # IVS5342274; 5) IV START LD KIT , CATALOG # IVS5342273; 6) IV START LD KIT , CATALOG # IVS5342272; 7) IV START LD KIT , CATALOG # IVS5342271; 8) IV START LD KIT , CATALOG # IVS534227B; 9) IV START BLOOD DRAW,KIT , CATALOG # BLDV125142; 10) RUN W/O SPKVM0102X , CATALOG # SPKVM01011; 11) IV START BLOOD DRAW, KIT , CATALOG # BLDHD03262; 12) IV START BLOOD DRAW, KIT , CATALOG # BLDHD0326C; 13) IV START BLOOD DRAW,KIT , CATALOG # BLDV125141; 14) IV START BLOOD DRAW,KIT , CATALOG # BLDHD03261; 15) KIT,IV START BLOOD DRAW , CATALOG # BLDV12514A; 16) KIT,IV START, , CATALOG # IVSJV83001; 17) IV START LD KIT , CATALOG # IVS534227A; 18) IV START BLOOD DRAW,KIT , CATALOG # PLHDBDHCH; 19) IV START BLOOD DRAW, KIT , CATALOG # PLHDBDHCG; 20) IV START, ,KIT , CATALOG # PJJVIVMMU; 21) KIT,IV START L D , CATALOG # PZVQIVPAN; 22) IV START L D KIT , CATALOG # PZVQIVPAM; 23) KIT,IV START L D , CATALOG # PZVQIVPAM; 24) IV START BLOOD DRAW KIT , CATALOG # BLDHD0326B; 25) KIT,IV START BLOOD DRAW , CATALOG # BLDHD0326B; 26) KIT,IV START L D , CATALOG # PZVQIVPAO; 27) IV START, KIT , CATALOG # PJJVIVMMV; 28) IV START, , KIT , CATALOG # PJJVIVMMV; 29) KIT, IV START, , CATALOG # PJJVIVMMV; 30) IV START ,CHILD KIT, CATALOG # PX29IVACAC; 31) IV START BLOOD DRAW KIT , CATALOG # BLDHD0326A; 32) IV START KIT , CATALOG # PZ82IVTCI; 33) I V START,NMH KIT , CATALOG # PZVBIVNMQ.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 11 products — see all of them.

Details

Units affected
221554 kits
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, Illinois, United States
Classification
Class I
Recall number
Z-0218-2027

In the FDA's words

Description
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) IV START LD KIT , CATALOG # IVS5342277; 2) IV START LD KIT , CATALOG # IVS5342276; 3) IV START LD KIT , CATALOG # IVS5342275; 4) IV START LD KIT , CATALOG # IVS5342274; 5) IV START LD KIT , CATALOG # IVS5342273; 6) IV START LD KIT , CATALOG # IVS5342272; 7) IV START LD KIT , CATALOG # IVS5342271; 8) IV START LD KIT , CATALOG # IVS534227B; 9) IV START BLOOD DRAW,KIT , CATALOG # BLDV125142; 10) RUN W/O SPKVM0102X , CATALOG # SPKVM01011; 11) IV START BLOOD DRAW, KIT , CATALOG # BLDHD03262; 12) IV START BLOOD DRAW, KIT , CATALOG # BLDHD0326C; 13) IV START BLOOD DRAW,KIT , CATALOG # BLDV125141; 14) IV START BLOOD DRAW,KIT , CATALOG # BLDHD03261; 15) KIT,IV START BLOOD DRAW , CATALOG # BLDV12514A; 16) KIT,IV START, , CATALOG # IVSJV83001; 17) IV START LD KIT , CATALOG # IVS534227A; 18) IV START BLOOD DRAW,KIT , CATALOG # PLHDBDHCH; 19) IV START BLOOD DRAW, KIT , CATALOG # PLHDBDHCG; 20) IV START, ,KIT , CATALOG # PJJVIVMMU; 21) KIT,IV START L D , CATALOG # PZVQIVPAN; 22) IV START L D KIT , CATALOG # PZVQIVPAM; 23) KIT,IV START L D , CATALOG # PZVQIVPAM; 24) IV START BLOOD DRAW KIT , CATALOG # BLDHD0326B; 25) KIT,IV START BLOOD DRAW , CATALOG # BLDHD0326B; 26) KIT,IV START L D , CATALOG # PZVQIVPAO; 27) IV START, KIT , CATALOG # PJJVIVMMV; 28) IV START, , KIT , CATALOG # PJJVIVMMV; 29) KIT, IV START, , CATALOG # PJJVIVMMV; 30) IV START ,CHILD KIT, CATALOG # PX29IVACAC; 31) IV START BLOOD DRAW KIT , CATALOG # BLDHD0326A; 32) IV START KIT , CATALOG # PZ82IVTCI; 33) I V START,NMH KIT , CATALOG # PZVBIVNMQ. Kits contain infusion sets which were recalled for performance issues. CATALOG # IVS5342277, GTIN 10888439967814 (ea) 50888439967812 (cs), LOT #540480; CATALOG # IVS5342277, GTIN 10888439967814 (ea) 50888439967812 (cs), LOT #540480; CATALOG # IVS5342276, GTIN 10888439820690 (ea) 50888439820698 (cs), LOT #425675; CATALOG # IVS5342276, GTIN 10888439820690 (ea) 50888439820698 (cs), LOT #425675; CATALOG # IVS5342275, GTIN 10888439793628 (ea) 50888439793626 (cs), LOT #404845; CATALOG # IVS5342275, GTIN 10888439793628 (ea) 50888439793626 (cs), LOT #404845; CATALOG # IVS5342275, GTIN 10888439793628 (ea) 50888439793626 (cs), LOT #404845; CATALOG # IVS5342275, GTIN 10888439793628 (ea) 50888439793626 (cs), LOT #404845; CATALOG # IVS5342274, GTIN 10888439783810 (ea) 50888439783818 (cs), LOT #395356; CATALOG # IVS5342274, GTIN 10888439783810 (ea) 50888439783818 (cs), LOT #395356; CATALOG # IVS5342273, GTIN 10888439676181 (ea) 50888439676189 (cs), LOT #365114; CATALOG # IVS5342273, GTIN 10888439676181 (ea) 50888439676189 (cs), LOT #365114; CATALOG # IVS5342272, GTIN 10888439626469 (ea) 50888439626467 (cs), LOT #331290; CATALOG # IVS5342272, GTIN 10888439626469 (ea) 50888439626467 (cs), LOT #331290; CATALOG # IVS5342271, GTIN 10888439542912 (ea) 50888439542910 (cs), LOT #267592; CATALOG # IVS5342271, GTIN 10888439542912 (ea) 50888439542910 (cs), LOT #267592; CATALOG # IVS5342271, GTIN 10888439542912 (ea) 50888439542910 (cs), LOT #267592; CATALOG # IVS534227B, GTIN 10888439419214 (ea) 50888439419212 (cs), LOT #208006; CATALOG # IVS534227B, GTIN 10888439419214 (ea) 50888439419212 (cs), LOT #208006; CATALOG # IVS534227B, GTIN 10888439419214 (ea) 50888439419212 (cs), LOT #208006; CATALOG # IVS534227B, GTIN 10888439419214 (ea) 50888439419212 (cs), LOT #233758; CATALOG # IVS534227B, GTIN 10888439419214 (ea) 50888439419212 (cs), LOT #233758; CATALOG # IVS534227B, GTIN 10888439419214 (ea) 50888439419212 (cs), LOT #254639; CATALOG # IVS534227B, GTIN 10888439419214 (ea) 50888439419212 (cs), LOT #254639; CATALOG # IVS534227B, GTIN 10888439419214 (ea) 50888439419212 (cs), LOT #254639; CATALOG # IVS534227B, GTIN 10888439419214 (ea) 50888439419212 (cs), LOT #276605; CATALOG # IVS534227B, GTIN 10888439419214 (ea) 50888439419212 (cs), LOT #305961; CATALOG # BLDV125142, GTIN 10887488259383 (ea) 50887488259381 (cs), LOT #334078; CATALOG # BLDV125142, GTIN 10887488259383 (ea) 50887488259381 (cs), LOT #334078; CATALOG # SPKVM01011, GTIN 10887488254340 (ea) 50887488254348 (cs), LOT #345717; CATALOG # BLDHD03262, GTIN 10887488237480 (ea) 50887488237488 (cs), LOT #329751; CATALOG # BLDHD03262, GTIN 10887488237480 (ea) 50887488237488 (cs), LOT #329751; CATALOG # BLDHD0326C, GTIN 10887488237473 (ea) 50887488237471 (cs), LOT #335787; CATALOG # BLDHD0326C, GTIN 10887488237473 (ea) 50887488237471 (cs), LOT #335787; CATALOG # BLDHD0326C, GTIN 10887488237473 (ea) 50887488237471 (cs), LOT #335787; CATALOG # BLDHD0326C, GTIN 108874882
Hazard
Kits contain infusion sets which were recalled for performance issues.

11 products in this recall

Cardinal Health Presource kits recalled for infusion set issues

FDA classified this as a Class I recall of 11 Cardinal Health Presource PBDS kits, distributed in the US and Canada. Each kit contains BD Alaris Pump Infusion Sets for use with the BD Alaris Pump Module Model 8100, and the infusion sets were recalled for performance issues. The kits are labeled with names such as anesthesia, cath lab, C-section, labor, and emergency kits. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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