CooperSurgical Recalls

CooperSurgical, Inc. recalls Cooper Surgical 2 MHZ Waterproof OB Probe Product The Coo

The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

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CooperSurgical, Inc. recalls CooperSurgical lnflatoball Latex Rubber Pessary sold as an i

The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.

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CooperSurgical, Inc. recalls Endosee System Convenience Kit with IV Tube. Model Number: E

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

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CooperSurgical, Inc. recalls Endosee System Convenience Kit. Model Number: ES-TRAY. E

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

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CooperSurgical, Inc. recalls HSG Procedure Tray. Model Number: 6050T. The HSG Procedu

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

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CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: G85 Mini Incubator Mod

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

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CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: T47 Warming Plate Mode

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

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CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: Multiple/unknown Model

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

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CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: G73 Dry Bath Incubator

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

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CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: T47 Warming Plate Mode

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

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CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: R65 Trolley Model/Cata

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

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CooperSurgical, Inc. recalls Stainless Steel Sims Uterine Sound, Part Number 64-601

During the manufacturing process the devices were laser-marked with the incorrect part number.

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CooperSurgical, Inc. recalls Origio Sperm Wash Medium Pack of Five 60ml bottles - Intende

Low concentration of sodium pyruvate in the wash could compromise gamete development

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CooperSurgical, Inc. recalls Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended

Low concentration of sodium pyruvate in the wash could compromise gamete development

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CooperSurgical, Inc. recalls Origio Sperm Wash Medium Pack of Five 60ml bottles - Intende

Low concentration of sodium pyruvate in the wash could compromise gamete development

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CooperSurgical, Inc. recalls Silver-Plated Copper Sims Uterine Sound, Part Number 64-600

During the manufacturing process the devices were laser-marked with the incorrect part number.

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CooperSurgical, Inc. recalls global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-05

The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.

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CooperSurgical, Inc. recalls Box as labeled: Regard, Carter-Thomason CloseSure System XL,

Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.

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CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administeri

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

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CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administ

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

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CooperSurgical, Inc. recalls CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

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CooperSurgical, Inc. recalls Global Total LP single step medium, 60mL, bicarbonate-buffer

It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.

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CooperSurgical, Inc. recalls BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for bl

The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.

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CooperSurgical, Inc. recalls NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540

Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient's mouth. In one case, the patient suffered a laceration to the throat.

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CooperSurgical, Inc. recalls Humidifier bottle and syringe filter kit (6 count of each) f

There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation.

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CooperSurgical, Inc. recalls Humidifier bottle and syringe filter kit (6 count of each) f

There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation.

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CooperSurgical, Inc. recalls LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.

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CooperSurgical, Inc. recalls VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The Vitri

Products in this lot may have compromised barrier seals, introducing a risk to sterility.

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CooperSurgical, Inc. recalls Quantum 2000 Electrosurgical Generators Cooper Surgical Par

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

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