Reported Feb 15, 2023 · Ongoing
Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c.…
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Sterile Procedural Trays
- labeled as the followinga. 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
- Lot codes and dates
23 of 23 products
Products covered by this recall Model / number Barcodes Product as published 1088994200046340889942000464PORT/TRACH INSERTION CDS-3, Item Number: CDS983004D, Case UDI/GTIN: 40889942000464, Unit UDI/ , Lot Number: 22IBF922,22IBE764 1019532723535240195327235353RESIDENT DERM SURG PACK, Item Number: DYNDA2997, Case UDI/GTIN: 40195327235353, Unit UDI/ , Lot Number: 22JBR611 1088994221159340889942211594THROMBECTOMY PACK-LF, Item Number: DYNJ0160348B, Case UDI/GTIN: 40889942211594, Unit UDI/ , Lot Number: 22IDB621 1019348938376840193489383769AV FISTULA PACK, Item Number: DYNJ01966N, Case UDI/GTIN: 40193489383769, Unit UDI/ , Lot Number: 22IMA429 1019348922653940193489226530AV SHUNT PACK-LF, Item Number: DYNJ0781844W, Case UDI/GTIN: 40193489226530, Unit UDI/ , Lot Number: 22IMG652 1019348941282640193489412827RR-VP SHUNT PACK-LF, Item Number: DYNJ0785917M, Case UDI/GTIN: 40193489412827, Unit UDI/ , Lot Number: 22GMH382 1019348937797240193489377973VEIN HARVESTING PACK-LF, Item Number: DYNJ0826732I, Case UDI/GTIN: 40193489377973, Unit UDI/ , Lot Number: 22IMF839 1019348938429140193489384292AV FISTULA PACK-LF, Item Number: DYNJ0826753O, Case UDI/GTIN: 40193489384292, Unit UDI/ , Lot Number: 22JMH548,22IMC908 1019348921345440193489213455PK, GEN-BARIATRIC, Item Number: DYNJ33890B, Case UDI/GTIN: 40193489213455, Unit UDI/ , Lot Number: 22JBV659,22HBW898 1019532707803440195327078035VEIN PACK, Item Number: DYNJ36309F, Case UDI/GTIN: 40195327078035, Unit UDI/ , Lot Number: 22IMC227 1019532714871340195327148714VENOUS ACCESS PACK-LF, Item Number: DYNJ36725D, Case UDI/GTIN: 40195327148714, Unit UDI/ , Lot Number: 22HBO043 1019348998334040193489983341VENOUS ACCESS PACK, Item Number: DYNJ42694A, Case UDI/GTIN: 40193489983341, Unit UDI/ , Lot Number: 22JBK167,22IBJ914 1088994294330240889942943303VASCULAR ACCESS PACK, Item Number: DYNJ45071C, Case UDI/GTIN: 40889942943303, Unit UDI/ , Lot Number: 22IBO914 1019532714872040195327148721ARTERIOGRAM PACK, Item Number: DYNJ53095A, Case UDI/GTIN: 40195327148721, Unit UDI/ , Lot Number: 22IBM491,22HBY446 1088994272188740889942721888AV FISTULA/GRAFT INSER PK, Item Number: DYNJ57152, Case UDI/GTIN: 40889942721888, Unit UDI/ , Lot Number: 22IBT472 1019532703095740195327030958VEIN ABLATION PACK, Item Number: DYNJ62889B, Case UDI/GTIN: 40195327030958, Unit UDI/ , Lot Number: 22JDB544 1019348921214340193489212144PORT PACK, Item Number: DYNJ64675, Case UDI/GTIN: 40193489212144, Unit UDI/ , Lot Number: 22IBP112 1019532709632840195327096329MINOR VASCULAR, Item Number: DYNJ66148A, Case UDI/GTIN: 40195327096329, Unit UDI/ , Lot Number: 22JBL900,22HBP630,22HBG264 1019348935850640193489358507FISTULA PACK, Item Number: DYNJ66502, Case UDI/GTIN: 40193489358507, Unit UDI/ , Lot Number: 22HBO053 1019348948216440193489482165AV FISTULA-LF, Item Number: DYNJ901747K, Case UDI/GTIN: 40193489482165, Unit UDI/ , Lot Number: 22JDC010,22JDA876 - Amount recalled
- 622 cases (1,619 units)
This recall covers 38 products
The agency filed one notice per product. You are reading one of them; the other 37 are below.
25 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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