CLASS II Device recall · Reported 18 Apr 2018 · FDA Enforcement Report
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS recalled
Ethicon is recalling PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet Armed CTB-1 Needle, distributed nationwide in the US. The recall was initiated on 10 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-1340-2018
- FDA event ID
- 79541
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2018
- FDA classified
- 10 Apr 2018
- Reported
- 18 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 10 Jan 2018 | Recall initiated by company | |
| 10 Apr 2018 | Classified by FDA | +90 days |
| 18 Apr 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
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Product as listed by the FDA
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
Where it was distributed
Distribution US Nationwide, Canada, India, and Colombia.
Questions about this recall
Is PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet Armed CTB-1 Needle recalled?
Yes. Ethicon recalled PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet Armed CTB-1 Needle on 10 Jan 2018. The recall is Class II and its status is Terminated. Recall number Z-1340-2018.
Why was it recalled?
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Which lots are affected?
Product code: PDPB346 GTIN: 10705031048829 Product lot: LMM273
Where was it sold?
Distribution US Nationwide, Canada, India, and Colombia.
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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