Pediatric Two-Lumen Central Venous Catheterization Kit with Blue… — Class II medical device recall Z-2886-2018
Terminated recall by Arrow International Inc, reported 2018-08-29, distributed in AL, CA, IL, MA, MO, NH, NM, NY…. One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this
| Recall number | Z-2886-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2018-07-03 |
| Classified | 2018-08-22 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2020-04-29 |
| Distributed | AL, CA, IL, MA, MO, NH, NM, NY, TX, UT, VA, WI |
| Quantity | 166 |
| Reason classes | labeling |
| Model numbers | AK-22502 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2886-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.