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McKesson

MCKESSON MEDICAL-SURGICAL INC. · Model 16-F610 · UDI-DI 10612479213651

GBMEZD Prescription
10
510(k) clearances
2,601
Adverse events (4 deaths)
18
Recalls
79
Facilities

Description

Catheter Urethral Female 6" 10FR

Recalls

DateFirmReason
2026-07-14Hollister UlcHollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary
2025-11-29HANGZHOU BEVER MEDICAL DEVICES CO., LTD.Labeling error, Incorrect expiration date
2023-12-04Cardinal Health 200, LLCConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2018-03-15Teleflex Medical Europe LtdThese products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause All
2011-04-21Coloplast Manufacturing US, LLCColoplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the ov
2008-07-17Apogee Medical, IncDue to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis
2008-07-17Apogee Medical, IncDue to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis
2008-07-17Apogee Medical, IncDue to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis
2008-07-17Apogee Medical, IncDue to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.