98 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.
FDA Recall
Terminated
·SRI Surgical·Product code FTN·July 16, 2008
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.
FDA Enforcement
Class II
·Terminated·SRI Surgical·September 5, 2012
Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285
FDA Enforcement
Class II
·Terminated·Ansell Healthcare Products LLC·December 28, 2016
ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018480, Size 8, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011
ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011
ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018470, Size 7, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011
ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011
ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018455, Size 5 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011
ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018485, Size 8 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011
ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018465, Size 6 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011
ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018475, Size 7 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code KGO·May 1, 2009
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code KGO·May 1, 2009
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8514, Size 7, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code KGO·May 1, 2009
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code KGO·May 1, 2009
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code KGO·May 1, 2009
ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Processing Zone, Biyagama, Sri Lanka Intended use: Surgical Gloves
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code KGO·September 3, 2010
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8518, Size 9, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code KGO·May 1, 2009
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8517, Size 8 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code KGO·May 1, 2009
Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code KGO·October 24, 2016