Colorado recalls

Cook Medical recalled certain Flexor Check-Flo Introducer and Set models because some units were manufactured out of specification. Affected devices may have been cut to incorrect lengths, not properly trimmed, or not inspected properly. This is a medical device used in vascular procedures.

Diasol has recalled a bicarbonate dialysis liquid concentrate (product 100425-10-DEX100, lot PHV08042) because the FDA cannot confirm it is safe and effective for use. The recall affects approximately 2,200 gallons distributed across Missouri, California, Arizona, Texas, Illinois, and Massachusetts.

Safety and efficacy of dialysis acid concentrate cannot be assured

Diasol, Inc. is recalling specific lots of its 100230-10-DEX100 bicarbonate dialysis liquid concentrate because the safety and efficacy of the product cannot be assured. The affected product was distributed nationwide in Missouri, California, Arizona, Texas, Illinois, and Massachusetts. No injuries have been reported.

Diasol, Inc. is recalling a dialysis acid concentrate product because the safety and efficacy of the product cannot be assured. The recall affects 4,400 gallons of product distributed nationwide to medical facilities in Missouri, California, Arizona, Texas, Illinois, and Massachusetts.

Diasol has recalled specific lots of its liquid concentrate used in bicarbonate dialysis machines. The FDA determined that the safety and efficacy of this product cannot be assured. The recall affects 7,200 gallons distributed across six states.

Diasol is recalling specific lots of its bicarbonate dialysis liquid concentrate because the safety and efficacy of the product cannot be assured. The affected product was distributed nationwide to dialysis facilities in Missouri, California, Arizona, Texas, Illinois, and Massachusetts. No injuries have been reported.

Microbiologics Inc. is recalling certain LYFO DISK products containing Campylobacter jejuni subsp. jejuni (Catalog Number 0325L) because affected units may fail to recover the target microorganism as intended. This affects laboratory testing and quality control processes.

Microbiologics Inc. recalled certain KWIK-STIK 6-Pack bacterial culture products (Catalog Number 0325K) because affected units may fail to properly recover the target microorganism Campylobacter jejuni subsp. jejuni. This means laboratory and testing professionals using these products may not be able to verify that the cultures are viable or suitable for their intended testing purposes.

Microbiologics Inc. has recalled specific lots of KWIK-STIK 2-Pack test kits used to detect Campylobacter jejuni bacteria. The affected units may fail to correctly recover the target microorganism, which could lead to false negative test results in laboratory testing.

Zimmer, Inc. is recalling certain Affixus 9 mm femoral nails (Model 815509300, Lot 66717550) used in hip and thigh bone fracture surgery. Some implants may have a thinner-than-expected diameter that could cause the nail to fracture over time, potentially requiring additional surgery.

Zimmer, Inc. is recalling a specific batch of Affixus Antegrade Femoral Nails (9 mm, 280 mm length, left Piriformis) used in thigh bone fracture repair. The affected implants may have a manufacturing defect that weakens the nail shaft and could cause it to break inside the leg. If this happens, patients may experience pain, improper bone healing, or need another surgery.

Zimmer has recalled certain Affixus Antegrade Femoral Nails (model 815609440) used in hip fracture surgery. Some implants may have a manufacturing defect that makes them thinner than intended, which could cause the implant to crack or break over time. This could lead to pain, improper healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails (9 mm, 420 mm length, left side) used in thighbone fracture surgery. Some implants may have a manufacturing defect that weakens the nail shaft, increasing the risk of the implant breaking inside the leg.

Zimmer Affixus Antegrade Femoral Nails (9 mm, 400 mm length, left side) may have a smaller-than-intended diameter along the shaft. This could cause the implant to weaken and break over time, leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific Affixus Antegrade Femoral Nailing System implants (model 815609380, 9 mm, 380 mm length, left side) because they may have a manufacturing defect that makes the shaft undersized. This defect could cause the implant to break over time, potentially requiring additional surgery.

Zimmer, Inc. recalled certain Affixus Antegrade Femoral Nails (9 mm, 360 mm length, left side) because the shaft may be undersized and could fracture over time. A fractured implant could cause pain, improper bone healing, or require additional surgery.

Zimmer, Inc. recalled specific lots of Affixus Antegrade Femoral Nails (9 mm, 340 mm, Left) because the implant shaft may be undersized. This could cause the nail to break over time after surgical implantation, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer has recalled certain Affixus 9 mm femoral nails (320 mm length, left side) because the metal shaft may be undersized. This defect could cause the implant to crack over time, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling certain Affixus 9 mm, 300 mm Left Trochanteric Femoral Nails (Model 815609300, Lot 66717600) because the implant shaft may be undersized, which could cause it to crack or break inside the body. If the nail fractures, patients may experience pain, improper bone healing, tissue damage, or need another surgery.

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (model 815509440, 440 mm length) because the implant shaft may be undersized. This defect could cause the nail to break over time, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific lots of the Affixus Antegrade Femoral Nailing System (a surgical implant used to stabilize thighbone fractures) because some units may have a manufacturing defect that could cause the implant to crack or break over time. If the implant breaks, it could lead to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails (model 815509400, 9 mm, 400 mm length) used in thigh bone surgery. Some implants may have a manufacturing defect that makes the shaft undersized, which could cause the nail to fracture over time.

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (9 mm, 380 mm length, right-sided) because the implant shaft may be undersized. This manufacturing defect could cause the implant to break inside the body, potentially leading to pain, improper bone healing, or the need for additional surgery.

Zimmer, Inc. recalled certain Affixus 9 mm femoral nails (model 815509360, length 360 mm) because the shaft may be undersized and prone to breaking. If the implant fractures, it could cause pain, improper bone healing, tissue damage, or require additional surgery.

Zimmer, Inc. recalled 22 Affixus Antegrade Femoral Nails (9 mm, 340 mm length, right-sided) because the implants may have an undersized shaft diameter that could cause the nail to break inside the leg over time. If the implant fractures, it may cause pain, improper bone healing, tissue damage, or require additional surgery.

Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (9 mm, 320 mm length, right-sided) because the implant shaft may be undersized. This manufacturing defect could cause the nail to break over time, which may lead to pain, bone healing problems, or the need for additional surgery.

ICU Medical's LifeShield Infusion Safety Software v2.2 has a software issue that limits concentration settings to one decimal place instead of three. This may force users to set drug limits differently than the manufacturer recommends, potentially causing patients to receive too much or too little medication.

ICU Medical's LifeShield Drug Library Management software version 2.2.1 has a problem where the Change Summary review tool stops working correctly after a library migration. This affects only customers who upgraded from version 2.1x and use Plum Duo v1.1 infusion pumps. When the review tool doesn't work, staff may not catch errors in pump settings.

A faulty motor connector in certain da Vinci 5 surgical systems may cause Error 23062, which locks the surgeon console's ergonomic adjustments (viewer, headrest, armrest, and pedal position). This could delay or disrupt a scheduled surgical procedure. The issue affects 144 systems across 30 states.