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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85952

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 30, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
TELEFLEX MEDICAL INC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure gradients. To facilitate complete lung re-expansion to restore normal breathing dynamics.

Z-2748-2020
Recall number
Z-2748-2020
Initiated
June 30, 2020
Classification
Class II
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
204644 each (OUS)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised¿

Code information

Lot Numbers: 74A1602932 74A1703007 74A1802909 74A1900358 74A2001172 74A2002639 74B1600856 74B1600857 74B1700269 74B1701278 74B1702684 74B1801734 74B1900875 74B1901993 74B1902825 74B2000066 74B2000361 74C1700392 74C1701906 74C1703150 74C1801547 74C1801548 74C2000213 74C2000214 74C2000473 74C2000754 74C2002285 74D1600915 74D1800630 74D1800632 74D1900143 74D1900144 74D1902087 74E1600936 74E1700397 74E1701189 74E1701196 74E1702207 74E1800301 74E1801286 74E1802464 74E1900510 74E1901525 74F1502198 74F1600345 74F1600460 74F1600461 74F1603155 74F1702091 74F1702491 74F1800692 74F1802178 74F1901722 74G1601816 74G1602512 74G1700142 74G1701822 74G1801551 74G1900712 74G1901738 74G1902569 74H1602162 74H1602618 74H1701206 74H1703208 74H1801031 74H1802122 74H1900242 74H1900251 74H1902213 74J1500448 74J1500865 74J1600969 74J1700548 74J1702261 74J1703038 74J1800939 74J1801384 74J1801385 74J1902581 74K1500387 74K1502281 74K1600247 74K1601780 74K1700695 74K1701305 74K1701886 74K1801271 74K1801272 74K1900069 74K1902094 74L1600158 74L1602510 74L1800465 74L1800953 74L1801262 74L1901155 74L1901156 74L1901427 74L1901428 74L1902305 74L1902306 74M1600558 74M1700229 74M1800724 74M1801532

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of FL, PR and the countries of AL, BR, CR, EC, ES, GB, GR, HK, HN, ID, IT, MX, PA, PE, PH, PK, PR, SG, SV, VE.

device · product 2 of 2

Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure gradients. To facilitate complete lung re-expansion to restore normal breathing dynamics.

Z-2749-2020
Recall number
Z-2749-2020
Initiated
June 30, 2020
Classification
Class II
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
1812 each (US)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised¿

Code information

Lot Numbers: 74A1801125 74A1902739 74A2000267 74A2000268 74A2000745 74A2000746 74A2000747 74A2001170 74A2001171 74A2001934 74A2001935 74A2001936 74B1800758 74B2000067 74B2000068 74B2000363 74B2000364 74C1800921 74C1801541 74C1900767 74C1902202 74C2000217 74C2000474 74C2001737 74C2001769 74C2001770 74D1700243 74D1801534 74D1802402 74D1902703 74E1701799 74E1900882 74E1901526 74F1500554 74F1500555 74F1500731 74F1700647 74F1700648 74F1702092 74F1900390 74F1900391 74F1901723 74G1600770 74G1601461 74G1801221 74G1900713 74H1502743 74H1502805 74H1800551 74H1802708 74H1802709 74H1900252 74H1901558 74J1500223 74J1500904 74J1502363 74J1800509 74J1802225 74J1802226 74J1900253 74J1901144 74J1901636 74K1500375 74K1500917 74K1501031 74K1502282 74L1500196 74L1500197 74L1500198 74L1801592

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of FL, PR and the countries of AL, BR, CR, EC, ES, GB, GR, HK, HN, ID, IT, MX, PA, PE, PH, PK, PR, SG, SV, VE.