Recall Weekly
Serious riskFDA DeviceClass I

Arrow International AHDC kits recalled for possible sterility risk

Arrow International included injectable medications (lidocaine, bupivacaine, and sodium chloride) from a supplier with quality issues in several catheter kit models. If the sterility of these water-based injectable products is compromised, patients could face serious or life-threatening infections.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have any affected kit lot numbers (full list available in recall details)
  2. Do not use affected kits; contact your healthcare provider or hospital pharmacy for replacement
  3. Return unused kits to your supplier or contact Arrow International for instructions
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A-U; LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XN1A
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 35 products — see all of them.

Details

Units affected
4,270
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2374-2026

In the FDA's words

Description
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A-U; LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XN1A Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. REF(Material)/UDI-DI/Lot(Batch): AK-12123-PCDC/10801902193275, 10801902168471/33F24J0419, 33F25B0015, 33F25F0022, 33F25G0482, 33F25J0029, 33F25K0268, 33F26B0056, 33F24E0175; AK-15123-PCDC/10801902186499, 10801902193275, 10801902168532/33F24G0140, 33F24J0449, 33F24M0074, 33F25B0040, 33F25J0604, 33F24A0767; CDC-15123-XP1A/10801902193275, 30801902111822, 10801902213430/33F25D0438, 33F25E0649, 33F25H0579, 33F25J0313, 33F26B0161, 33F26C0198, 33F24D0355; CDC-16123-XP1A/10801902193275, 40801902111867/33F25D0612, 33F25G0291, 33F25H0578, 33F26C0190, 33F24L0469; CDC-16123-XPN1A/10801902193275, 10801902196498/33F25J0113, 33F24D0974; CDC-25122-XN1A-U/10801902193275/33F25J0114, 33F25B0621; CDC-22123-XN1A/50801902123515/33F24D0928 Distribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR. Affected quantity: 4,270
Hazard
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

35 products in this recall

Arrow kits with lidocaine and bupivacaine recalled for sterility risk

Arrow is recalling 35 kits and sets that contain lidocaine, bupivacaine, or 0.9% sodium chloride from a supplier that was itself recalled for quality issues. If the sterility of these water-based injectable drugs is compromised, it could lead to serious or life-threatening injuries. No injuries have been reported, and the products were distributed nationwide.

The agency lists each product separately. Check every one you might have.

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