CLASS II ONGOING Device recall · Reported 20 Nov 2019 · FDA Enforcement Report
Peg Guide Extender recalled by TriMed
TriMed is recalling TriMed Peg Guide Extender, distributed nationwide in the US. The recall was initiated on 28 Sep 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-0358-2020
- FDA event ID
- 83820
- Recalling firm
- TriMed, Santa Clarita, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Sep 2018
- FDA classified
- 12 Nov 2019
- Reported
- 20 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 28 Sep 2018 | Recall initiated by company | |
| 12 Nov 2019 | Classified by FDA | +410 days |
| 20 Nov 2019 | 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
The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
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
TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Where it was distributed
Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Questions about this recall
Is Peg Guide Extender recalled?
Yes. TriMed recalled Peg Guide Extender on 28 Sep 2018. The recall is Class II and its status is Ongoing. Recall number Z-0358-2020.
Why was it recalled?
The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
Which lots are affected?
Lot number 2858, 2861, and 3749
Where was it sold?
Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
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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