Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Procedural Trays

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Sterile Procedural Trays see related information
Date Initiated by Firm November 17, 2022
Date Posted February 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-1068-2023
Recall Event ID 91386
Product Classification Central venous catheter tray - Product Code OFF
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
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;
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer Reason
for Recall		 Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-