Agency classClass IIOur severity:High FDA (Devices)·Z-0569-2023·Announced 2022-12-21

DeRoyal PICC line trays recalled due to sterile drape defects

DeRoyal Industries is recalling 918 PICC line procedure packs containing 3M sterile drapes that were separately recalled. The affected kits were distributed across 23 U.S. states to healthcare facilities.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall of medical device procedure packs used in healthcare settings. Although no reported injuries are documented, sterile drape defects in procedure packs pose an inherent risk of patient harm through infection or complications, fitting the rubric criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

DeRoyal Industries Inc is recalling 918 PICC line procedure packs (REF 89-6150.13). The recalled packs contain 3M Health Care Steri Drapes that have been subject to a separate recall.

The affected lot numbers are: 56005273 (expiration 5/1/2024), 56657845 (expiration 5/1/2024), 57021523 (expiration 8/1/2024), 57392244 (expiration 8/1/2024), and 57770575 (expiration 3/1/2025). These packs were distributed across 23 U.S. states: Alabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Wisconsin.

Healthcare facilities that have received these recalled procedure packs should immediately verify their inventory using the affected lot numbers and contact DeRoyal Industries Inc regarding appropriate replacement products and corrective actions.

The recalled product

Product: DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Procedure Pack
Hazard: sterile-drape-defect
Affected units: 918

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Lot Numbers: Lot 56005273 exp 5/1/2024
Lot 56657845 exp 5/1/2024
Lot 57021523 exp 8/1/2024
Lot 57392244 exp 8/1/2024
Lot 57770575 exp 3/1/2025

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 156 products in this recall →

Same manufacturer · DeRoyal Industries Inc

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