Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 28, 2015
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a
the Instructions for Use (IFU) were inadvertently removed from the kit.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Arrow International Inc recalled Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13… - a moderate-severity action.
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13… was recalled by Arrow International Inc in January 28, 2015. Reason: the Instructions for Use (IFU) were inadvertently removed from the kit.. Check the official notice for the remedy. Verify recall #Z-1005-2015 with the FDA Devices before acting.
The recall
Arrow International Inc issued this moderate-severity FDA Devices recall-the Instructions for Use (IFU) were inadvertently removed from the kit..
- Moderate
- severity level
- 420 units
- affected scope
- Class II
- classification
- January 28, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1005-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1005-2015) was formally reported on January 28, 2015, with the manufacturer initiating the action on December 16, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Arrow International Inc is listed as the recalling firm, operating out of Reading, PA. Federal records list the affected scope as 420.
The documented reason for this recall is: the Instructions for Use (IFU) were inadvertently removed from the kit. Distribution data in the federal record shows the product reached: In the state of KY. 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, 3 from FDA Devices - 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 - 40,322 medical devices recalls on record
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
420
Related Recalls
6
3 from same agency
Product description
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Reason for recall
the Instructions for Use (IFU) were inadvertently removed from the kit.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1005-2015 |
| Date reported | January 28, 2015 |
| Date initiated | December 16, 2014 |
| Recalling firm | Arrow International Inc |
| Firm location | Reading, PA |
| Affected scope | 420 |
| Distribution | In the state of KY |
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-1005-2015) 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? ▼
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.. Recalled by Arrow International Inc. Units affected: 420.
Why was this product recalled? ▼
the Instructions for Use (IFU) were inadvertently removed from the kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 28, 2015. Severity: Moderate. Recall number: Z-1005-2015.
Where was the recalled product distributed? ▼
Distribution: In the state of KY.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1005-2015) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 28, 2015. 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.