Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 29, 2018
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is intended to help provide protection against catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use. The use of the 4, 5, and 5.5 F
One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Arrow International Inc recalled Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blu… - a moderate-severity action.
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blu… was recalled by Arrow International Inc in August 29, 2018. Reason: One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, th…. Check the official notice for the remedy. Verify recall #Z-2886-2018 with the FDA Devices before acting.
The recall
Arrow International Inc issued this moderate-severity FDA Devices recall-One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, th….
- Moderate
- severity level
- 166 units
- affected scope
- Class II
- classification
- August 29, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2886-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2886-2018) was formally reported on August 29, 2018, with the manufacturer initiating the action on July 3, 2018. 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 166.
The documented reason for this recall is: One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm cathet… Distribution data in the federal record shows the product reached: Distributors in MO and UT. Medical facilities in AL, CA, IL, MA, NH, NM, NY, TX, VA, and WI.. 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
166
Related Recalls
6
3 from same agency
Product description
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is intended to help provide protection against catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use. The use of the 4, 5, and 5.5 Fr. antimicrobial surface catheters in infants weighing less than 2.0, 2.5, and 3.0 kilograms respectively, have not been evaluated. Therefore, the benefits of these catheters in infants weighing less than the indicated weights should be weighed against any possible risks.
Reason for recall
One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient injuries have been reported related to this issue.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2886-2018 |
| Date reported | August 29, 2018 |
| Date initiated | July 3, 2018 |
| Recalling firm | Arrow International Inc |
| Firm location | Reading, PA |
| Affected scope | 166 |
| Distribution | Distributors in MO and UT. Medical facilities in AL, CA, IL, MA, NH, NM, NY, TX, VA, and WI. |
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-2886-2018) 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? ▼
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is intended to help provide protection against catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use. The use of the 4, 5, and 5.5 Fr. antimicrobial surface catheters in infants weighing less than 2.0, 2.5, and 3.0 kilograms respectively, have not been evaluated. Therefore, the benefits of these catheters in infants weighing less than the indicated weights should be weighed against any possible risks.. Recalled by Arrow International Inc. Units affected: 166.
Why was this product recalled? ▼
One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient injuries have been reported related to this issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2018. Severity: Moderate. Recall number: Z-2886-2018.
Where was the recalled product distributed? ▼
Distribution: Distributors in MO and UT. Medical facilities in AL, CA, IL, MA, NH, NM, NY, TX, VA, and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2886-2018) 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 August 29, 2018. 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.