CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
1 Stratafix Spiral PDS Plus Violet 18" OS-6 Needle, SXPP1B201 recalled
Ethicon is recalling 1 Stratafix Spiral PDS Plus Violet 18" OS-6 Needle, SXPP1B201. The recall was initiated on 28 Aug 2019 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-1334-2020
- FDA event ID
- 84772
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2019
- FDA classified
- 20 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 28 Aug 2019 | Recall initiated by company | |
| 20 Feb 2020 | Classified by FDA | +176 days |
| 26 Feb 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product do not meet certain internal testing specifications.
Product as listed by the FDA
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
Where it was distributed
International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
Questions about this recall
Why was it recalled?
The product do not meet certain internal testing specifications.
Which lots are affected?
GTIN: 10705031235861 Lot Number: PAH360 Expiration Date: 12/31/2020
Where was it sold?
International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 84772| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 1 Stratafix" Spiral PDS Plus Violet 36" CTX Needle, SXPP1B402 recalled | Ethicon | Other | NJ | |
| CLASS II | 1 Stratafix" Spiral PDS Plus Violet 12" CT-1 Needle, SXPP1B429 recalled | Ethicon | Other | NJ |
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|---|---|---|---|---|---|
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