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Important Customer Notices (ICNs)

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Showing 99 ICNs only belonging to tag: Field Safety Notice Clear filter

Field Safety Notice FVCA – 2023-001 Avanos Ballard Oral Care Swab Incorrect Expiry Dates (ICN 2062)

Ref: 2023/2062 - 21 July 2023

Important Customer Notice: Update

Avanos has updated its Field Safety Advisory Notice FCA-2023-001, issuing a second notice dated 15 June 2023, to include an additional lot number.

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Field Safety Notice Smith and Nephew No Sting Prep Wipes and Swabs ELY463 (ICN 2202)

Ref: 2023/2202 - 20 July 2023

Important Customer Notice: Field Safety Notice

The supplier Smith and Nephew has issued a Field Safety Notice withdrawing specific batches of No-Sting Wipes and Swabs.

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Field Safety Notice Wyvern Medical Dental Products (ICN 2177)

Ref: 2023/2177 - 30 June 2023

Important Customer Notice: Field Safety Notice

Please be advised the lot numbers and expiry dates have been corrected following a system error.

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Field Safety Notice Getinge Maquet Structural Heart Products Product Recall Datascope Sensation, Sensation Plus, Mega and Linear IAB Catheters (ICN 2180)

Ref: 2023/2180 - 30 June 2023

Important Customer Notice: Field Safety Notice

In addition to the previous notification of the Field Safety Notice, NHS England has issued a letter and Best Practice Guidance dated 27 June 2023, reference PR00584_i and PRN00584_ii, regarding Getinge Maquet Structural Heart Products.

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Field Safety Notice Masimo TC-1 Reusable Tip Clip Sensor Product Recall – Specific Lot Numbers Only (ICN 2181)

Ref: 2023/2181 - 28 June 2023

Important Customer Notice: Field Safety Notice

Masimo has issued following identifying that some lot numbers of the TC- I Reusable Tip Clip sensors have a higher-than-expected variability in SpO2 readings that are outside of the accuracy specification.

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Field Safety Notice Flexicare BriteBlade Product Recall (ICN 2183)

Ref: 2023/2183 - 28 June 2023

Important Customer Notice: Field Safety Notice

The supplier Flexicare has issued a Field Safety Notice affecting the BriteBlade Pro Single-use Flexible McCoy Type Blade Size 4 due to the potential that the blade is not sterile as indicated on the product packaging.

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Field Safety Notice Smiths Medical CADD™ Infusion System Infusion Sets for use with CADD Pumps (ICN 1968)

Ref: 2022/1968 - 22 June 2023

Important Customer Notice: Update

Smith’s Medical has updated FA2211-01 due to identifying additional lot numbers of CADD Infusion System Infusion sets that are potentially affected by the issues listed in the initial Field Safety Notice.

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Field Safety Notice Teleflex Medical Endotracheal Tubes (ICN 2149)

Ref: 2023/2149 - 8 June 2023

Important Customer Notice: Update

In addition to the previous notification of the Field Safety Notice, a further six product codes have been identified and are affected.

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Field Safety Notice Integra LifeSciences Product Recall Biologic mesh (ICN 2157)

Ref: 2023/2157 - 5 June 2023

Important Customer Notice: Field Safety Notice

Integra Lifesciences has issued a Field Safety Notice recalling a range of fixation devices as listed in Appendix 1.

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Field Safety Notice Hemospray Endoscopic Haemostat (ICN 2151)

Ref: 2023/2151 - 1 June 2023

Important Customer Notice: Field Safety Notice

This Field Safety Notice is to bring heightened awareness of the potential risks of hemospray powder adhering to the distal end of the endoscope.

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Field Safety Notice Polyflush Pre-filled Syringes (ICN 2143)

Ref: 2023/2143 - 24 May 2023

Important Customer Notice: Field Safety Notice

Poly Medicure Ltd, via distributor GBUK Limited, has issued a Field Safety Notice for its Polyflush Syringe, 0.9% Sodium chloride (0.9% NaCl), Saline Solution Pre-Filled Syringe-10ml Single Sterile.

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Field Safety Notice Arrow Intra-Aortic Balloon Pumps Potential Short Battery Run Times (ICN 2134)

Ref: 2023/2134 - 22 May 2023

Important Customer Notice: Field Safety Notice

Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a precautionary Field Safety Corrective Action (FSCA) for the Arrow AutoCat 2 and AC3 Optimus intra-aortic balloon pumps.

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Field Safety Notice Medtronic SenSight ™ Extension Tunneller Kit Product Recall (ICN 2133)

Ref: 2023/2133 - 15 May 2023

Important Customer Notice: Field Safety Notice

Medtronic has issued a Field Safety Notice recalling a range of Lot numbers following reports of the SenSight™ Extension Tunneller kit that contains dual carriers have been machined on one side only.

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Product Recall Icelock Ratchet Medical Devices (ICN 2124)

Ref: 2023/2124 - 9 May 2023

Important Customer Notice: Recall

The supplier Ossur has issued a Field Safety Notice recalling a range of Icelock Ratchet devices due to a lock release issue.

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Field Safety Notice Philips 12-Lead Chest Lead-set (AAMI/IEC) FJE6389 (ICN 1852)

Ref: 2022/1852 - 27 April 2023

Important Customer Notice: Update

The supplier Philips Medical has issued an Important Product Notice related to the Philips 12-Lead Chest Lead-set (AAMI/IEC), FJE6389.

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