Shellfish Recalls in the United States

ICU Medical, Inc. recalls Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-

Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

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ICU Medical, Inc. recalls Product Description/Item: ChemoLock Bag Spike, 10 units/CL-1

Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

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ICU Medical, Inc. recalls 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psi

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

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ICU Medical, Inc. recalls 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 Micro

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

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Associates of Cape Cod, Inc. recalls Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum R

Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes

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Baxter Healthcare Corporation recalls Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

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Baxter Healthcare Corporation recalls Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMP

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

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Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplifica

The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.

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MEDLINE INDUSTRIES, LP - Northfield recalls Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reo

The CirClamp subassembly found in the kit was the incorrect size.

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MEDLINE INDUSTRIES, LP - Northfield recalls Centurion manual surgical kits labeled as: a) STERILE TUBE

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER F

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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MEDLINE INDUSTRIES, LP - Northfield recalls Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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Smiths Medical ASD Inc. recalls Smiths Medical Model 3010 Syringe pumps: a. Protege Model

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

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Smiths Medical ASD Inc. recalls Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numb

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

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Smiths Medical ASD Inc. recalls Smiths Medical Medfusion Guide Barrel Clamp, Item number G60

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

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Smiths Medical ASD Inc. recalls Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbe

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

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MEDLINE INDUSTRIES, LP - Northfield recalls Medline Procedure kits labeled as: 1) CIRCUMCISION SET, P

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

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MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

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MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedural kits labeled as: 1) CIRCUMCISION TRAY,

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

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