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ARROW INTERNATIONAL Recalls
525 recalls on record · June 27, 2012 to June 24, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 19, 2020Medical DevicesFDA
Arrow International Inc recalls FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
Hazard: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
February 19, 2020Medical DevicesFDA
Arrow International Inc recalls FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM
Hazard: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
February 19, 2020Medical DevicesFDA
Arrow International Inc recalls TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
Hazard: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
February 19, 2020Medical DevicesFDA
Arrow International Inc recalls FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
Hazard: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
February 19, 2020Medical DevicesFDA
Arrow International Inc recalls EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B
Hazard: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
February 19, 2020Medical DevicesFDA
Arrow International Inc recalls FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
Hazard: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
February 19, 2020Medical DevicesFDA
Arrow International Inc recalls FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E
Hazard: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
February 19, 2020Medical DevicesFDA
Arrow International Inc recalls FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B
Hazard: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
January 29, 2020Medical DevicesFDA
Arrow International Inc recalls Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral
Hazard: The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
January 29, 2020Medical DevicesFDA
Arrow International Inc recalls Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Hazard: Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.
December 25, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Hazard: Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
December 25, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
Hazard: Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
October 30, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and
Hazard: Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length
October 16, 2019Medical DevicesFDA
Arrow International Inc recalls Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Prod
Hazard: Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
October 2, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arro
Hazard: Products may contain the incorrect banner card within the kit
October 2, 2019Medical DevicesFDA
Arrow International Inc recalls 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Produc
Hazard: Products may contain the incorrect banner card within the kit
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow¿ PICC with Chlorag+ard¿ Technology Product Code:PR 45552 HPHNM
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45552 HPHNL
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow¿ PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45541 HPHNL
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42063 HPHNM
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 VPS2
Hazard: Lidstock states the incorrect expiration date for the product
June 26, 2019Medical DevicesFDA
Arrow International Inc recalls Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 HPK1A
Hazard: Lidstock states the incorrect expiration date for the product