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Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT...

FDA Device Recall #Z-1068-2023 — Class II — November 17, 2022

Recall Summary

Recall Number Z-1068-2023
Classification Class II — Moderate risk
Date Initiated November 17, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 622 cases (1,619 units)

Product Description

Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j. VEIN PACK k. VENOUS ACCESS PACK-LF l. VENOUS ACCESS PACK m. VASCULAR ACCESS PACK n. ARTERIOGRAM PACK o. AV FISTULA/GRAFT INSER PK p. VEIN ABLATION PACK q. PORT PACK r. MINOR VASCULAR s. FISTULA PACK t. AV FISTULA-LF u. AV FISTULA v. PORT VENOUS ACCESS w. AV FISTULA

Reason for Recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Lot / Code Information

a. PORT/TRACH INSERTION CDS-3, Item Number: CDS983004D, Case UDI/GTIN: 40889942000464, Unit UDI/GTIN: 10889942000463, Lot Number: 22IBF922,22IBE764; b. RESIDENT DERM SURG PACK, Item Number: DYNDA2997, Case UDI/GTIN: 40195327235353, Unit UDI/GTIN: 10195327235352, Lot Number: 22JBR611; c. THROMBECTOMY PACK-LF, Item Number: DYNJ0160348B, Case UDI/GTIN: 40889942211594, Unit UDI/GTIN: 10889942211593, Lot Number: 22IDB621; d. AV FISTULA PACK, Item Number: DYNJ01966N, Case UDI/GTIN: 40193489383769, Unit UDI/GTIN: 10193489383768, Lot Number: 22IMA429; e. AV SHUNT PACK-LF, Item Number: DYNJ0781844W, Case UDI/GTIN: 40193489226530, Unit UDI/GTIN: 10193489226539, Lot Number: 22IMG652; f. RR-VP SHUNT PACK-LF, Item Number: DYNJ0785917M, Case UDI/GTIN: 40193489412827, Unit UDI/GTIN: 10193489412826, Lot Number: 22GMH382; g. VEIN HARVESTING PACK-LF, Item Number: DYNJ0826732I, Case UDI/GTIN: 40193489377973, Unit UDI/GTIN: 10193489377972, Lot Number: 22IMF839; h. AV FISTULA PACK-LF, Item Number: DYNJ0826753O, Case UDI/GTIN: 40193489384292, Unit UDI/GTIN: 10193489384291, Lot Number: 22JMH548,22IMC908; i. PK, GEN-BARIATRIC, Item Number: DYNJ33890B, Case UDI/GTIN: 40193489213455, Unit UDI/GTIN: 10193489213454, Lot Number: 22JBV659,22HBW898; j. VEIN PACK, Item Number: DYNJ36309F, Case UDI/GTIN: 40195327078035, Unit UDI/GTIN: 10195327078034, Lot Number: 22IMC227; k. VENOUS ACCESS PACK-LF, Item Number: DYNJ36725D, Case UDI/GTIN: 40195327148714, Unit UDI/GTIN: 10195327148713, Lot Number: 22HBO043; l. VENOUS ACCESS PACK, Item Number: DYNJ42694A, Case UDI/GTIN: 40193489983341, Unit UDI/GTIN: 10193489983340, Lot Number: 22JBK167,22IBJ914; m. VASCULAR ACCESS PACK, Item Number: DYNJ45071C, Case UDI/GTIN: 40889942943303, Unit UDI/GTIN: 10889942943302, Lot Number: 22IBO914; n. ARTERIOGRAM PACK, Item Number: DYNJ53095A, Case UDI/GTIN: 40195327148721, Unit UDI/GTIN: 10195327148720, Lot Number: 22IBM491,22HBY446; o. AV FISTULA/GRAFT INSER PK, Item Number: DYNJ57152, Case UDI/GTIN: 40889942721888, Unit UDI/GTIN: 10889942721887, Lot Number: 22IBT472; p. VEIN ABLATION PACK, Item Number: DYNJ62889B, Case UDI/GTIN: 40195327030958, Unit UDI/GTIN: 10195327030957, Lot Number: 22JDB544; q. PORT PACK, Item Number: DYNJ64675, Case UDI/GTIN: 40193489212144, Unit UDI/GTIN: 10193489212143, Lot Number: 22IBP112; r. MINOR VASCULAR, Item Number: DYNJ66148A, Case UDI/GTIN: 40195327096329, Unit UDI/GTIN: 10195327096328, Lot Number: 22JBL900,22HBP630,22HBG264; s. FISTULA PACK, Item Number: DYNJ66502, Case UDI/GTIN: 40193489358507, Unit UDI/GTIN: 10193489358506, Lot Number: 22HBO053; t. AV FISTULA-LF, Item Number: DYNJ901747K, Case UDI/GTIN: 40193489482165, Unit UDI/GTIN: 10193489482164, Lot Number: 22JDC010,22JDA876; u. AV FISTULA, Item Number: DYNJ903417F, Case UDI/GTIN: 40193489418218, Unit UDI/GTIN: 10193489418217, Lot Number: 22KBF261,22KBG353; v. PORT VENOUS ACCESS, Item Number: DYNJ903426F, Case UDI/GTIN: 40193489418447, Unit UDI/GTIN: 10193489418446, Lot Number: 22JBR462,22JBB174,22HBS253; w. AV FISTULA, Item Number: DYNJ903726B, Case UDI/GTIN: 40193489966849, Unit UDI/GTIN: 10193489966848, Lot Number: 22KBD044,22IBO370,22HBX959;

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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