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Terminated

Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

FDA Recall Z-0199-2023 · Posted 2022-11-08

Recalling FirmAccess Vascular, Inc.
Recall StatusTerminated
Product CodeLJS
Date Initiated2021-02-24
Date Terminated2024-05-30
Product Quantity79 kits

Reason for Recall

Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

Firm Action

Beginning February 24, 2021, the firm notified its affected consignees via Email. Customers were informed that if product had already been used, then no action was required, because all components were still within their expiration date at the time, and no patient safety risk was identified. If product had not been used, customers were asked to refrain from using product until a replacement Scalpel and Statlock were provided.

Root Cause

Process design

Distribution Pattern

Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K193015HydroPICC (PICC-142)Access Vascular, Inc. · 2020-02-20

Official Source

View FDA Recall →

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

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