CLASS II Device recall · Reported 18 Jul 2018 · FDA Enforcement Report
Bard Mypicc Kit recalled by Medline Industries
Medline Industries is recalling Bard Mypicc Kit, distributed in Utah. The recall was initiated on 12 Jan 2018 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-2378-2018
- FDA event ID
- 80197
- Recalling firm
- Medline Industries, Waukegan, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jan 2018
- FDA classified
- 6 Jul 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 12 Jan 2018 | Recall initiated by company | |
| 6 Jul 2018 | Classified by FDA | +175 days |
| 18 Jul 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One of the cases of product might not have been sterilized.
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
BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
Where it was distributed
The product was distributed to UT.
Questions about this recall
Is Bard Mypicc Kit recalled?
Yes. Medline Industries recalled Bard Mypicc Kit on 12 Jan 2018. The recall is Class II and its status is Terminated. Recall number Z-2378-2018.
Why was it recalled?
One of the cases of product might not have been sterilized.
Which lots are affected?
Lot 17YM5936, Exp. 04/30/2019
Where was it sold?
The product was distributed to UT.
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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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |