Recall Weekly
Serious riskFDA DeviceClass I

Arrow PICC kits recalled for possible sterility risk

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality issues in multiple PICC (peripherally inserted central catheter) kit models. The supplier's products may be ineffective or contaminated, and compromised sterility in injectable products can cause serious infection or injury.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have any affected Arrow International PICC kits by matching the product reference numbers and lot numbers provided in the recall notice.
  2. Do not use affected kits. Contact your healthcare provider or facility immediately if you have already received care with a recalled kit.
  3. Return unused kits to Arrow International or your supplier.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURVB AGBA PICC NaviCurve: 2L 5.5FR x 55CM TCG/DLX-45552-CURVC AGBA PICC: 2L 5.5FR x 55CM w Biopatch/DLX-45552-HPKB AGBA PICC NaviCurve: 3L 6FR x 55CM BP/DLX-45563-CURVB PI PICC KIT: 4 FR X 50 CM/ASK-35041-NH PI PICC KIT: 2-L 5 FR X 50 CM/ASK-35052-NH PI PICC G4 Stylet: 1L 4FR x 55CM w CHG/DLX-35541-VPSC PI PICC NaviCurve: 2L 5FR x 55CM w BP/DLX-35552-CURVB PI PICC NaviCurve: 3L 6FR x 55CM w BP/DLX-35563-CURVB PI PICC G4 Stylet: 3L 6FR x 55CM w BP/DLX-35563-VPSB AGBA PI PICC KIT: 2L 5.5 FR X 55CM/CDC-45552-HPK1A PI AGBA PICC KIT: 3-L 6 FR X 55 CM/CDC-45563-HPK1A PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI1 PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-VFH1 PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI1 PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-VFH1 PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS/ASK-45563-UWH1 AGBA PICC NaviCurve: 1L 4.5FR x 55CM BP/DLX-45541-CURVB AGBA PICC NaviCurve: 1L 4.5FR x 55CM TCG/DLX-45541-CURVC AGBA PICC G4 Stylet: 1L 4.5FR x 55CM TCG/DLX-45541-VPSC AGBA PICC G4 Stylet: 2L 5.5FR x 55CM BP/DLX-45552-VPSB AGBA PICC G4 Stylet: 2L 5.5FR x 55CM TCG/DLX-45552-VPSC PI PICC:1L 4FR X 50CM PRELOAD VPS STYLET/CDC-35041-VPS PICC KIT: 3 FR X 55 CM/CDC-05531-PK1A
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
37,738
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2370-2026

In the FDA's words

Description
Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURVB AGBA PICC NaviCurve: 2L 5.5FR x 55CM TCG/DLX-45552-CURVC AGBA PICC: 2L 5.5FR x 55CM w Biopatch/DLX-45552-HPKB AGBA PICC NaviCurve: 3L 6FR x 55CM BP/DLX-45563-CURVB PI PICC KIT: 4 FR X 50 CM/ASK-35041-NH PI PICC KIT: 2-L 5 FR X 50 CM/ASK-35052-NH PI PICC G4 Stylet: 1L 4FR x 55CM w CHG/DLX-35541-VPSC PI PICC NaviCurve: 2L 5FR x 55CM w BP/DLX-35552-CURVB PI PICC NaviCurve: 3L 6FR x 55CM w BP/DLX-35563-CURVB PI PICC G4 Stylet: 3L 6FR x 55CM w BP/DLX-35563-VPSB AGBA PI PICC KIT: 2L 5.5 FR X 55CM/CDC-45552-HPK1A PI AGBA PICC KIT: 3-L 6 FR X 55 CM/CDC-45563-HPK1A PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI1 PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-VFH1 PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI1 PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-VFH1 PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS/ASK-45563-UWH1 AGBA PICC NaviCurve: 1L 4.5FR x 55CM BP/DLX-45541-CURVB AGBA PICC NaviCurve: 1L 4.5FR x 55CM TCG/DLX-45541-CURVC AGBA PICC G4 Stylet: 1L 4.5FR x 55CM TCG/DLX-45541-VPSC AGBA PICC G4 Stylet: 2L 5.5FR x 55CM BP/DLX-45552-VPSB AGBA PICC G4 Stylet: 2L 5.5FR x 55CM TCG/DLX-45552-VPSC PI PICC:1L 4FR X 50CM PRELOAD VPS STYLET/CDC-35041-VPS PICC KIT: 3 FR X 55 CM/CDC-05531-PK1A 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): ASK-44063-NS/10801902193275/33F25F0100; ASK-45052-NS/10801902193275/33F24L0864 ASK-45541-MHBV/10801902193275, 10801902167696/33F25D0410, 33F26C0012, 33S24A0690, 33F25B0574; ASK-45552-RH/10801902193275/33F25B0575, 33F25D0361, 33F25F0197, 33F25K0373, 33F25A0082; DLX-45552-CURVB/10801902193275, 10801902208702/33F25E0506, 33F25E0833, 33F26C0038, 33S24B0518, 33F24L0982; DLX-45552-CURVC/10801902193275, 10801902208733/33F25B0386, 33F25D0381, 33F25D0624, 33F25E0765, 33F25F0225, 33F25H0602, 33F26C0182, 33F25B0390; DLX-45552-HPKB/10801902193275, 10801902208825, 10801902208856/33F25D0454, 33F25D0677, 33F25E0834, 33F25J0446, 33F25M0172, 33F26B0867, 33S24A0586, 33S24A1370, 33F24F0097; DLX-45563-CURVB/10801902193275/33F25C0339, 33F25E0836, 33F25A0321; ASK-35041-NH/10801902221077, 10801902193275/33F26B0140 33F25G0460; ASK-35052-NH/10801902193275/33F25H0412, 33F24L1080; DLX-35541-VPSC/10801902193275/33F25C0449, 33F25D0245, 33F25H0501, 33F24L1148; DLX-35552-CURVB/10801902193275, 10801902208764/33F25C0214, 33F25E0511 ,33F25E0832 ,33F26C0120 33F26C0732, 33F25C0373; DLX-35563-CURVB/10801902193275, 10801902208771/33F25C0337, 33F26B0155, 33F25D0453; DLX-35563-VPSB/10801902193275/33F25C0395; CDC-45552-HPK1A/10801902193275, 10801902188462/33F25D0067, 33F25D0243, 33F25E0452, 33F25E0658, 33F25E0829, 33F26B0891, 33F26C0202, 33S23K0168, 33S24A0419, 33S24A0523, 33S24A1387, 33F25K0317; CDC-45563-HPK1A/10801902193275, 10801902188479/33F25G0283, 33F25H0626, 33S24A0543, 33F24D0497; ASK-45541-UOI1/10801902193275, 10801902221664/33F25H0411, 33F25J0399, 33S24A1368, 33F26A0226; ASK-45541-VFH1/10801902193275, 10801902218886/33F25B0655, 33F25E0573, 33F25G0210, 33F26A1533, 33F26B0841, 33F25G0584; ASK-45552-UOI1/10801902193275/33F26A0227; ASK-45552-VFH1/10801902193275/33F25D0362, 33F25E0866, 33F25J0226, 33F25M0180, 33F26A1455, 33F25H0408; ASK-45563-UWH1/10801902193275/33F25D0660, 33F25J0227, 33F24K0066; DLX-45541-CURVB/10801902193275/33F25B0385, 33F25D0250, 33F25E0760, 33F25J0336, 33F25K0194, 33F24L1115; DLX-45541-CURVC/10801902193275/33F25B0507, 33F25C0216, 33F25E0761, 33F25F0223, 33F25G0362, 33F25J0337, 33F25E0762; DLX-45541-VPSC/10801902193275, 10801902208610/33F24L0390, 33F24L1130, 33F25C0247, 33F25D0251, 33F25D0380, 33F25D0623, 33F25E0764, 33F25E0900, 33F25F0224, 33F25H0604, 33F25J0445, 33F26A1541, 33F26B0460, 33F26C0220, 33F26C0717, 33F25B0387; DLX-45552-VPSB/10801902193275/33F25C0249, 33F25D0253, 33F25D0314, 33F25D0382, 33F24L0392; DLX-45552-VPSC/10801902193275, 10801902208634/33F24L0939, 33F25B0508, 33F25D0254, 33F25D0315, 33F25D0383,33F25D0626, 33F25E0581, 33F25E0709, 33F25E0835, 33F25J0129, 33F25J0257, 33F25M0167, 33F26B0712, 33F26B0937, 33F25B0388; CDC-35041-VPS/10801902186741, 10801902193275/33X25K0001, 33F25E0425; CDC-05531-PK1A/10801902193275, 60801902123420/33F25C0641, 33F25D0435, 33F25E0646, 33F25J0416, 33F26B0711, 33F25D0765 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
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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