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Terminated

McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

FDA Recall Z-0119-2019 · Posted None

Recalling FirmCypress Medical Products LLC
Recall StatusTerminated
Product CodeFMF
Date Initiated2018-09-04
Date Terminated2024-05-28
Product Quantity400 cases

Reason for Recall

Small hole at the end of the syringe is impeding suction of liquid.

Firm Action

Cypress Medical Products LLC notified the distributor, McKesson Medical-Surgical, on 9/4/18. McKesson Medical-Surgical is responsible for communications to the distribution centers and end users. Any material on hand at end user facilities will be returned to the McKesson DC. Accounts requested to cease distribution and quarantine product for return. A response form included with letter to be completed and returned.

Root Cause

Equipment maintenance

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993017PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGEShinchang Medical Co., Ltd. · 2000-02-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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