Medline Industries, Lp: Cesarean Section Tray
Cesarcan Section Tray Recall Summary Medline is recalling two medical procedure kits (D and C Pack and PK Cust CV A&B Cabrini Co) used in cesarean section and related procedures because some catheters in the kits had surface irregularities, connectors that detached prematurely, or outer diameters that didn't meet specifications. The kits were distributed nationwide in the US and to several other countries. This is a Class II recall, meaning the products could cause serious harm but are unlikely to cause death.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.
- Reason
- During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-04
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3566f15e-6993-461d-aa50-1850f8456b0c