Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 17, 2020
Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Arrow International Inc recalled Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US)… - a moderate-severity action.
Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US)… was recalled by Arrow International Inc in June 17, 2020. Reason: Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.. Check the official notice for the remedy. Verify recall #Z-2288-2020 with the FDA Devices before acting.
The recall
Arrow International Inc issued this moderate-severity FDA Devices recall-Nine complaints reported that the rotatable collar on the filter had detached, causing a leak..
- Moderate
- severity level
- Class II
- classification
- June 17, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2288-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2288-2020) was formally reported on June 17, 2020, with the manufacturer initiating the action on May 8, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Arrow International Inc is listed as the recalling firm, operating out of Reading, PA. Federal records list the affected scope as 109 eaches (US), 23,021 (OUS).
The documented reason for this recall is: Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. Distribution data in the federal record shows the product reached: US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
109 eaches (US), 23,021 (OUS)
Related Recalls
6
0 from same agency
Product description
Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Reason for recall
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2288-2020 |
| Date reported | June 17, 2020 |
| Date initiated | May 8, 2020 |
| Recalling firm | Arrow International Inc |
| Firm location | Reading, PA |
| Affected scope | 109 eaches (US), 23,021 (OUS) |
| Distribution | US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2288-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.. Recalled by Arrow International Inc. Units affected: 109 eaches (US), 23,021 (OUS).
Why was this product recalled? ▼
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2288-2020.
Where was the recalled product distributed? ▼
Distribution: US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2288-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported June 17, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.