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McKesson S697GXRecalls & reported problems

Mckesson Medical-Surgical Inc. · SUTURE *6-0 NYLON 18 DSM11 · Class 2 · Implant

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10612479214481), received between Aug 17, 2022 and Aug 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K900531); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Dec 2, 2022Open, Classified

    Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

    Z-1173-2023 · Root cause: Packaging process control · FDA record ↗

  2. Dec 2, 2022Open, Classified

    Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

    Z-1176-2023 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURES WERE BREAKING OFF AT THE NEEDLE SITE.

    Patient problems: Insufficient Information

    MAUDE report 15240896 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900531. One submission often covers many models, so check the product and lot details in each record.

  • Z-1174-2023 · Dec 2, 2022 · Open, Classified
    Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 10

Other Suture, Nonabsorbable, Synthetic, Polyamide devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.