CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report
SafeStep Huber Needle Set myPICK Port Access Kit recalled
Becton Dickinson & is recalling SafeStep Huber Needle Set myPICK Port Access Kit. The recall was initiated on 19 Jun 2020 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-2665-2020
- FDA event ID
- 85853
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jun 2020
- FDA classified
- 18 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Syringes & Needles
Timeline
| 19 Jun 2020 | Recall initiated by company | |
| 18 Jul 2020 | Classified by FDA | +29 days |
| 29 Jul 2020 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)
Where it was distributed
Worldwide Distribution
Questions about this recall
Is SafeStep Huber Needle Set myPICK Port Access Kit recalled?
Yes. Becton Dickinson & recalled SafeStep Huber Needle Set myPICK Port Access Kit on 19 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2665-2020.
Why was it recalled?
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Which lots are affected?
Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695). Lot Numbers: REDZ0394 REDZ1664 REDZ3037 REEN1071 REER0578 REER1113 REEN0220 REEN0271 REEN5242 REEP2688 REDZ1486 REDZ1678 REEP1382 REER1973 Additional lot added 10/16/20: REEU0318
Where was it sold?
Worldwide Distribution
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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