# FDA recall Z-2040-2020

> **Medline Industries Inc** · Class II · device recall initiated 2020-03-09.

## 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 PACK	DYNJ30056J  ARTHRO/SHOULDER PACK	DYNJ30056K  ARTHRO/SHOULDER PACK	DYNJ30056L  ARTHRO/SHOULDER PACK	DYNJ30056M  BODY PACK	DYNJ55107A  BODY PACK	DYNJ55107C  BODY PACK	DYNJ55107D  C SECTION CDS	CDS984613D  C SECTION CDS	CDS830172I  C SECTION CDS	CDS984613F  C SECTION CDS	CDS830172J  C SECTION PACK	CMPJ17294I  C SECTION PACK-LF	DYNJ64834  CARDIAC A & B SJ PACK	DYNJ0619768D  CARDIAC PROCEDURE PACK	DYNJ63700  CLOSURE CDS	CDS983704D  CLOSURE CDS	CDS983704F  CLOSURE CDS	CDS983704G  COLECTOMY LAPAROSCOPIC	DYNJ906875  COLORECTAL ME	DYNJ906437  CRANIOTOMY	DYNJ905330A  CRANIOTOMY	DYNJ905330B  C-SECTION PACK	DYNJ32884F  C-SECTION PACK	DYNJ32884G  C-SECTION PACK	DYNJ32884I  C-SECTION PACK	DYNJ32884J  C-SECTION TRAY	DYNJ62

## Reason for recall

Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.

## Distribution

nationwide

## Key facts

- **Recall number:** Z-2040-2020
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-09
- **Report date:** 2020-05-27
- **Termination date:** 2022-02-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2040-2020

## Citation

> AI Analytics. FDA recall Z-2040-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2040-2020. Source: US FDA. Licensed CC0.

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