FDA Medical devices recall ·
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF recall
- Recall number
- Z-0777-2025
- Date
- (initiated November 21, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1236 units
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
Why was it recalled?
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) REF DYNJ0382559M, UDI/DI 10889942063994 (EA) 10889942063995 (CS), Lot Numbers: 19TBC792; 2) REF DYNJ56001B, UDI/DI 10889942798278 (EA) 40889942798279 (CS), Lot Numbers: 19BDC737, 19FDA310, 19FDB230, 19JDA441; 3) REF DYNJ66252, UDI/DI 10193489324785 (EA) 40193489324786 (CS), Lot numbers: 20DBK065, 20FBN251, 20HBL176, 20HBM692, 21CBP776; 4) REF DYNJ66252A, UDI/DI 10193489887853 (EA) 40193489887854 (CS), Lot numbers: 21IBN151, 21KBO915, 21LBJ105, 21VBB714; 5) REF DYNJ0578916X, UDI/DI 10193489288384 (EA) 40193489288385 (CS), Lot numbers: 22OBL262,20CKA219, 20CKA875, 20EKB076, 20GKA543, 20GKB272, 20IKB497, 20JKB716, 21AKA500, 21BKA195, 21FMD808, 21HMD657, 21IMB172, 21JMH627, 21KMH877, 21LMC161, 22AMA533, 22DMC612, 22DMI233, 22GMB685, 22IMA041, 23AMD730, 23DMA094, 23FMF542, 23IME618, 24AMA230.
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0777-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.