CLASS II Device recall · Reported 15 Aug 2018 · FDA Enforcement Report
162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump recalled
ICU Medical is recalling 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang, distributed nationwide in the US. The recall was initiated on 31 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2638-2018
- FDA event ID
- 80427
- Recalling firm
- ICU Medical, San Clemente, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jul 2017
- FDA classified
- 7 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 31 Jul 2017 | Recall initiated by company | |
| 7 Aug 2018 | Classified by FDA | +372 days |
| 15 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Where it was distributed
Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
Nationwide AlabamaArkansasCaliforniaConnecticutDelawareFloridaIowaIllinoisIndianaKansasMassachusettsMarylandMaineMichiganMissouriNorth CarolinaNew JerseyNew YorkOhioOregon
Questions about this recall
Is 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang recalled?
Yes. ICU Medical recalled 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang on 31 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-2638-2018.
Why was it recalled?
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Which lots are affected?
Item Number Z1278, Lot Number 70-577-SL, 70-753-SL, 71-103-Y1, 71-193-Y1, 71-536-Y1, 71-704-Y1, 71-989-Y1, 72-409-HE, 72-538-HE, 72-555-HE, 72-928-HE, 73-176-HE, 73-393-HE, 73-623-HE, 73-871-HE, 74-613-JW, 74-713-JW, 75-088-JW
Where was it sold?
Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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