CLASS II Device recall · Reported 6 Jun 2018 · FDA Enforcement Report
Continuous Nerve Block Needle recalled by Arrow International
Arrow International is recalling Continuous Nerve Block Needle, distributed nationwide in the US. The recall was initiated on 11 Apr 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-1958-2018
- FDA event ID
- 79890
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Apr 2018
- FDA classified
- 30 May 2018
- Reported
- 6 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 11 Apr 2018 | Recall initiated by company | |
| 30 May 2018 | Classified by FDA | +49 days |
| 6 Jun 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product sterility may be compromised due to unsealed packaging.
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
Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
Where it was distributed
US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
Questions about this recall
Is Continuous Nerve Block Needle recalled?
Yes. Arrow International recalled Continuous Nerve Block Needle on 11 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-1958-2018.
Why was it recalled?
Product sterility may be compromised due to unsealed packaging.
Which lots are affected?
Lot Numbers: 13F17G0253 13F17A0200 13F17F0505 13F17G0256 13F17J0455 13F17C0193 13F17K0105 13F17C0198 13F17J0280 13F17A0063 13F17A0061 13F17B0252 13F17F0190 13F17L0701 13F17A0064 13F17C0225 13F17D0342 13F17J0229 13F17K0592 13F17M0002 13F17A0201 13F17D0246
Where was it sold?
US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
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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