CLASS I Device recall · Reported 16 Jun 2021 · FDA Enforcement Report

Adult Chest Tube Tray recalled by Avid Medical

Avid Medical is recalling Adult Chest Tube Tray, distributed nationwide in the US. The recall was initiated on 9 Apr 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesPart Number: LAKC001-04; Package GTIN: 20809160261016; Lot Number: 1404809 (Expiration Date: 08/01/2021) and 1408337 (Expiration Date: 09/01/2021) Part Number: LAKC001-04; Package GTIN: 20809160293130; Lot Number: 1427628 (Expiration Date: 09/01/2021) Part Number: LAKC001-04; Package GTIN: 20809160313005; Lot number: 1427629 (Expiration Date: 09/01/2021), 1432814 (Expiration Date: 11/30/2021), and 1436046 (Expiration Date: 11/30/2021)

Quantity recalled130 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1784-2021
FDA event ID: 87720
Recalling firm: Avid Medical, Toano, VA
Classification: Class I
Status: Terminated
Recall initiated: 9 Apr 2021
FDA classified: 4 Jun 2021
Reported: 16 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

9 Apr 2021	Recall initiated by company
4 Jun 2021	Classified by FDA	+56 days
16 Jun 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04

Where it was distributed

Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN

Nationwide Arizona Illinois Louisiana Missouri Mississippi Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Part Number: LAKC001-04; Package GTIN: 20809160261016; Lot Number: 1404809 (Expiration Date: 08/01/2021) and 1408337 (Expiration Date: 09/01/2021) Part Number: LAKC001-04; Package GTIN: 20809160293130; Lot Number: 1427628 (Expiration Date: 09/01/2021) Part Number: LAKC001-04; Package GTIN: 20809160313005; Lot number: 1427629 (Expiration Date: 09/01/2021), 1432814 (Expiration Date: 11/30/2021), and 1436046 (Expiration Date: 11/30/2021)

Where was it sold?

Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 87720

This product is part of a recall event; the main page for the event is Fistula On-off Kit recalled by Avid Medical.

Reported	Class	Recall	Company	Reason	Where
16 Jun 2021	CLASS I	Fistula On-off Kit recalled by Avid Medical	Avid Medical	Packaging Defects	Nationwide
16 Jun 2021	CLASS I	Dialysis Access Medical convenience kit, Avid Medical recalled	Avid Medical	Packaging Defects	Nationwide
16 Jun 2021	CLASS I	Fistula (on/off) All recalled by Avid Medical	Avid Medical	Packaging Defects	Nationwide

More recalls from Avid Medical

All 184

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
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9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Halyard Total Joint recalled by AVID Medical	Avid Medical	Foreign Material	Nationwide

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All 13,778

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16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide