Z-1068-2023Class II
Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-11-17 / Open, Classified / root cause: design
MEDLINE INDUSTRIES, LP - Northfield began a recall of 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... on . FDA classified it as Class II and gives the reason as "Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1068-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- 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
- Product code
- OFF Central Venous Catheter Tray
- Reason for recall
- Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
- Quantity in commerce
- 622 cases (1,619 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Product codes and lots
- 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;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1060-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1061-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1062-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1063-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1064-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1065-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1066-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1067-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1068-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1069-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1070-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1071-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1072-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1073-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1074-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1075-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1076-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1077-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1078-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1079-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1080-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1081-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1082-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1083-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1084-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1085-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1086-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1087-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1088-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1089-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1090-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1091-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1092-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1093-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1094-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1095-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1096-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1097-2023 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.