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Infusion Pumps

🏥 Medical Devices • 4,262 recalls

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1500UP, IV ADMINISTRATION SET; Catalog Number: 490070.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DROPS/ML 125 IN; Catalog Number: 490452.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

Argon Medical Devices

Class I - Dangerous

Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied

Sep 12, 2025 Infusion Pumps Nationwide View Details →

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET W/2 CARESITE & 1 ULTRAPORT ZERO; ULTRAPORT Zer0 IV Set with CARESITE; Catalog Number: 457506.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. ANES SET W/DUAL FEM.LL SAFEPORT MANIFOLD; Catalog Number: 456520.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 81 IN W/ 32 IN EXT SET; Catalog Number: 490329.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. US1295 ULTRASITE IV ADMIN SET 60DROP; Catalog Number: 352394.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML 115 in.; Catalog Number: 490354.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB602VSL NON-VENT SET 103-IN-DR; Catalog Number: 352062.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Primary Gravity Filtered Set with 2 CARESITE¿ Injection Sites; IV ADM 15 DROP W/2 CARESITE FILTER; Catalog Number: 354207.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP W/ CARESITE EXT SET; Catalog Number: 490528. 2. 111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET; Catalog Number: 490550. 3. IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.; Catalog Number: 490605. 4. IV SET 15 DR 3CARESITE 2 ULTRAPORT; Catalog Number: 490616. 5. IV ADMIN SET, 2 CARSITE LADS; Catalog Number: 490654.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/2 CARESITE; Catalog Number: 354204. 2. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE; Catalog Number: 354205. 3. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE; Catalog Number: 354206.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET W/ 170¿M FILTER; Catalog Number: 480233.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15D, 144 IN.; Catalog Number: 490472.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108 IN; Catalog Number: 490189. 2. IV ADMIN SET 137 IN.; Catalog Number: 490226.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.

Mindray DS USA, Inc.

Class I - Dangerous

Potential for anesthesia leakage.

Oct 20, 2025 Infusion Pumps Nationwide View Details →

SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. UNIVERSAL IV ADMIN SET; Catalog Number: 352604. 2. SAFELINE ADDITIV ALTVTD 3 INJ S; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1251. 3. SAFELINE PED. ADDITIVE; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1290.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD.SET W/15 DR 128 IN, EXT SET 9 IN; Catalog Number: 490301.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. AS152V2DLL; Catalog Number: 473309.

B Braun Medical

Class I - Dangerous

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Oct 29, 2025 Infusion Pumps View Details →
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