Medline Recalls Surgical Kits Due to Potential Loss of Sterility
Medline is recalling 92,902 custom surgical convenience kits because packaging seal voids may have caused a loss of sterility on the outside of the foil pouch.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential loss of sterility in medical devices, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medline Industries Inc is recalling 92,902 custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products. The recall is due to a potential for voids in the packaging seal, which may have resulted in a loss of sterility on the outside of the foil pouch.
The affected products were distributed nationwide. The recall includes a wide variety of surgical packs and trays, such as abdominal hysterectomy, arthro/shoulder, body, C-section, cardiac, closure, colectomy, craniotomy, cysto, D&C, delivery, dental ENT, ear, general plastic, general, gynecologic, head and neck, heart, infant, knee arthroscopy, labor delivery, laminectomy, laparoscopic, lithotomy, major surgery, minor surgery, obstetrical, open heart, open urology, pediatrics, perineal, podiatry, rectal, robotic, shoulder, total hip, total joint, TUR, urology, vaginal, vascular, and WMC packs.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries Inc for further instructions. The specific part numbers and lot numbers are listed in the official recall documentation.
The recalled product
- Product
- Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PA
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 92,902
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- ABDOMINAL HYSTERECTOMY
- P/N DYNJ906478
- Lot Numbers: 19HDC844
- 19JDC085
- 19KDB380 ABDOMINAL HYSTERECTOMY
- P/N DYNJ906478A
- Lot Number 20BDB181 ACCESSORY HIP PACK-LF
- P/N DYNJ0781865M
- Lot Numbers: 18BK2574
- 18DK0496
- 18EKA073
- 18FKA858
- 18GKA188
- 18IKA759
- 18JKD361 ARTHRO/SHOULDER PACK
- P/N DYNJ30056J
- Lot Numbers: 17GB8081
- 18EBS087 ARTHRO/SHOULDER PACK
- P/N DYNJ30056K
- Lot Numbers: 18GBJ657
Distribution
Distributed nationwide across the United States.
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